Heart Failure, CongestivePhase 1NCT00742508

A Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients With Chronic Heart Failure

A Phase 1 study testing SK&F-105517-D 10 mg capsule, Carvedilol-immediate release (IR) 2.5 mg tablet and SK&F-105517-D 20 mg capsule in people with Heart Failure, Congestive, run by GlaxoSmithKline at 23 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to evaluate the safety and tolerability of SK\&F-105517-D in japanese patients with chronic heart failure. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Heart Failure, Congestive
What is being tested?: SK&F-105517-D 10 mg capsule, Carvedilol-immediate release (IR) 2.5 mg tablet and SK&F-105517-D 20 mg capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 23 sitesJapan
Study dates: 28 Aug 2008to 21 Aug 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with symptomatically stable chronic heart failure (CHF) based on ischemic heart disease or dilated cardiomyopathy
Patients who are maintained on basic heart failure therapy with angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blocker (ARB) and their dosage/administration is not changed within 2 weeks
Patients diagnosed with New York Heart Association (NYHA) class I to III
Patients with a left ventricular ejection fraction (LVEF) between 25% and 45%

Who cannot join

Patients contraindicated for ß-blockers
Patients with occurrence of acute myocardial infarction within 2 weeks
Patients with unstable angina, coronary spastic angina, or angina at rest
Patients who have collected blood >400 mL within 4 months prior to screening or >200 mL within 1 months

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

Japan23 sites

GSK Investigational Site
Chiba, 296-8602
GSK Investigational Site
Ehime, 794-0006
GSK Investigational Site
Hiroshima, 737-0023
GSK Investigational Site
Hokkaido, 060-0033
GSK Investigational Site
Hokkaido, 063-0005
GSK Investigational Site
Kanagawa, 210-0852
GSK Investigational Site
Kanagawa, 238-8558
GSK Investigational Site
Mie, 511-0068
GSK Investigational Site
Nagano, 397-8555
GSK Investigational Site
Nagasaki, 859-3615
GSK Investigational Site
Ōita, 879-5593
GSK Investigational Site
Osaka, 565-8565
GSK Investigational Site
Saga, 843-0393
GSK Investigational Site
Saitama, 364-8501
GSK Investigational Site
Shizuoka, 410-2295
GSK Investigational Site
Shizuoka, 411-8611
GSK Investigational Site
Shizuoka, 427-8502
GSK Investigational Site
Shizuoka, 430-8502
GSK Investigational Site
Tokyo, 141-0001
GSK Investigational Site
Tokyo, 142-8666
GSK Investigational Site
Tokyo, 153-8515
GSK Investigational Site
Tokyo, 196-0003
GSK Investigational Site
Wakayama, 640-8158

Other trials in Japan

About this study

Official title: A Study to Evaluate the Safety and Tolerability of SK&F-105517-D in Patients With Chronic Heart Failure- An Open-label Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SK&F-105517-D in Patients With Chronic Heart Failure (Phase I/II Study)

The primary objective of this study is to evaluate the safety and tolerability of SK\&F-105517-D in japanese patients with chronic heart failure.

Conditions: Heart Failure, Congestive
Being tested: SK&F-105517-D 10 mg capsule, Carvedilol-immediate release (IR) 2.5 mg tablet, SK&F-105517-D 20 mg capsule, SK&F-105517-D 40 mg capsule, Carvedilol-IR 10 mg tablet
Keywords: carvedilol phosphate, ß-blocker, SK&F-105517-D, Chronic heart failure(CHF)
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SK&F-105517-D 10 mg capsuleDrug
Also called carvedilol phosphate
1 capsule once a day
Carvedilol-immediate release (IR) 2.5 mg tabletDrug
1 or 2 tablet(s) twice a day
SK&F-105517-D 20 mg capsuleDrug
Also called carvedilol phosphate
1 capsule once a day
SK&F-105517-D 40 mg capsuleDrug
Also called carvedilol phosphate
1 or 2 capsule(s) once a day
Carvedilol-IR 10 mg tabletDrug
1 tablet twice a day

Study groups in NCT00742508
Study group	Role	What they receive
SK&F-105517-D group	Experimental	SK\&F-105517-D 10-80 mg/day Receives: Drug: SK&F-105517-D 10 mg capsule; Drug: SK&F-105517-D 20 mg capsule; Drug: SK&F-105517-D 40 mg capsule
Carvedilol-IR group	Other	Carvedilol-IR 5-20 mg/day Receives: Drug: Carvedilol-immediate release (IR) 2.5 mg tablet; Drug: Carvedilol-IR 10 mg tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D)
Drug-related adverse events (AEs) were defined as AEs that were judged to have a relationship with the investigational product by the investigator (or subinvestigator) with the use of clinical judgment and the Clinical Investigator Brochure to determine the relationship. Refer to adverse event information for type and frequency of adverse events.
Measured: Treatment Period from Week 0 (Baseline) to Week 8 and 1-week Follow-up Period (Week 9) for CRV-IR; Treatment Period from Week 0 (Baseline) to Week 14 and 1-week Follow-up Period (Week 15) for SK&F-105517-D
Mean Change From Baseline in Albumin and Total Protein at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Measured: Baseline and Week 8
Mean Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Creatine Kinase, and Gamma Glutamyl Transferase at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Measured: Baseline and Week 8
Mean Change From Baseline in Amylase at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Measured: Baseline and Week 8
Mean Change From Baseline in Total Bilirubin, Creatinine, and Uric Acid at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Measured: Baseline and Week 8
Mean Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Measured: Baseline and Week 8
Mean Change From Baseline in Creatine Kinase BB Percentage, Creatine Kinase MB Percentage, and Creatine Kinase MM Percentage at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value. (BB, brain-derived; MB=cardiac muscle-derived; MM=skeletal muscle-derived.
Measured: Baseline and Week 8
Mean Change From Baseline in Each Type of White Blood Cell (WBC) (Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils) at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Measured: Baseline and Week 8
Mean Change From Baseline in Hemoglobin and Mean Corpuscular Hemoglobin Concentration at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Measured: Baseline and Week 8
Mean Change From Baseline in Hematocrit at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Measured: Baseline and Week 8
Mean Change From Baseline in Platelet Count and White Blood Cell Count at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Measured: Baseline and Week 8
Mean Change From Baseline in Red Blood Cell Count at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Measured: Baseline and Week 8
Mean Change From Baseline in Mean Corpuscular Hemoglobin at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Measured: Baseline and Week 8
Mean Change From Baseline in Mean Corpuscular Volume at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Measured: Baseline and Week 8
Number of Participants With the Indicated Urinalysis Dipstick Results at Baseline and Week 8
Dipstick test values: Negative (-), Traces (+-), +1, +2, +3. +4. Normal ranges (qualitative): protein, - or +-; glucose, - or +-; occult blood, -; ketones, -.
Measured: Baseline and Week 8
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Measured: Baseline and Week 8
Mean Change From Baseline in Heart Rate at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Measured: Baseline and Week 8
Mean Change From Baseline in Weight at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Measured: Baseline and Week 8
Number of Participants With the Indicated Electrocardiogram Findings at Baseline and Week 8
There are 3 categories for electrocardiogram (ECG) findings: normal; abnormal, not clinically significant; and abnormal, clinically significant. Each of the findings was classified by the investigator according to whether it was normal. Abnormal ECGs were further classified according to whether they were felt to be clinically significant in the medical and scientific judgment of the investigator.
Measured: Baseline and Week 8
Cardiothoracic Ratio at Baseline and Week 8
Cardiothoracic ratio is a marker of the degree of heart enlargement and was measured by chest X-ray. It is shown as the ratio of the transverse diameter of the heart to the transverse diameter of the thorax, and is measured as a percentage.
Measured: Baseline and Week 8

Secondary outcomes (9)

Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8
Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 active Metabolite (SB-203231) were measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK\&F-105517-D group and Groups D, E, and F in the CRV-IR group. The analysis was performed on log-transformed data. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.
Measured: Week 8
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8
Area under the plasma concentration versus time curve from time zero to 24 hours (AUC0-24) of S-carvedilol, R-carvedilol, and M4 active metabolite (SB-203231) was measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK\&F-105517-D group and Groups D, E, and F in the CRV-IR group. The analysis was performed on log-transformed data. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.
Measured: Week 8
Time of Maximal Plasma Concentration (Tmax) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8
Time of maximal plasma concentration (tmax) of S-carvedilol, R-carvedilol, and M4 active metabolite (SB-203231) was measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK\&F-105517-D group and Groups D, E, and F in the CRV-IR group. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.
Measured: Week 8
Adjusted Mean Change From Baseline in Systolic Blood Pressure at Week 8
Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.
Measured: Baseline and Week 8
Adjusted Mean Change From Baseline in Diastolic Blood Pressure at Week 8
Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.
Measured: Baseline and Week 8
Adjusted Mean Change From Baseline in Mean Heart Rate at Week 8
Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.
Measured: Baseline and Week 8
Number of Participants With the Indicated Change From Baseline New York Heart Association (NYHA) Functional Class at Week 8
The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of. 4 classes: I, no resulting limitations on physical activity (PA); II, slight limitations on PA; III, marked limitations on PA; IV, inability to carry out any PA without discomfort. The number of participants with any change from Baseline in the NYHA Functional Class at Week 8 was calculated. Improved=class at the visit is decreased compared to baseline class, Unchanged=class at the visit is stable, Worsened=class at the visit is increased compared to baseline class.
Measured: Baseline and Week 8
Mean Plasma Brain Natriuretic Peptide Concentration at Baseline and Week 8
Brain natriuretic peptide is a surrogate marker of the severity of heart failure and was measured by a central laboratory.
Measured: Baseline and Week 8
Echocardiogram Results: Left Ventricular Ejection Fraction at Baseline and Week 8
Left ventricular ejection fraction (LVEF) is a marker of left ventricular systolic function and was measured by echocardiogram. It is shown as the ratio of left ventricular stroke volume (LVSV) to left ventricular end-diastolic volume (LVEDV), and is measured as a percentage.
Measured: Baseline and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 200821 Aug 2009

First posted27 Aug 2008 (estimated)
Study start28 Aug 2008
Primary completion21 Aug 2009
Study completion21 Aug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00742508
Sponsor's protocol ID: CRV110734
Status last verified: Jun 2017
First submitted: 26 Aug 2008
Last updated: 2 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Kitakaze M, Sarai N, Ando H, Sakamoto T, Nakajima H. Safety and tolerability of once-daily controlled-release carvedilol 10-80 mg in Japanese patients with chronic heart failure. Circ J. 2012;76(3):668-74. doi: 10.1253/circj.cj-11-0210. Epub 2012 Jan 12.
PubMed 22240593

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Heart Failure, Diastolic, Diastolic Heart Failure
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Heart Failure
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Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure, Congestive trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Safety and Tolerability of SK&F-105517-D in Patients With Chronic Heart Failure- An Open-label Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SK&F-105517-D in Patients With Chronic Heart Failure (Phase I/II Study)
ClinicalTrials.gov ID: NCT00742508
Acronym / sponsor ID: CRV110734
Conditions: Heart Failure, Congestive
Keywords: carvedilol phosphate, ß-blocker, SK&F-105517-D, Chronic heart failure(CHF)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 28 Aug 2008 (actual)
Primary completion: 21 Aug 2009 (actual)
Study completion: 21 Aug 2009 (actual)
First posted: 27 Aug 2008 (estimated)
Results: Posted 19 Aug 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of this study is to evaluate the safety and tolerability of SK\&F-105517-D in japanese patients with chronic heart failure.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SK&F-105517-D group	Experimental	Drug: SK&F-105517-D 10 mg capsule, Drug: SK&F-105517-D 20 mg capsule, Drug: SK&F-105517-D 40 mg capsuleSK\&F-105517-D 10-80 mg/day
Carvedilol-IR group	Other	Drug: Carvedilol-immediate release (IR) 2.5 mg tablet, Drug: Carvedilol-IR 10 mg tabletCarvedilol-IR 5-20 mg/day

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients with symptomatically stable chronic heart failure (CHF) based on ischemic heart disease or dilated cardiomyopathy
Patients who are maintained on basic heart failure therapy with angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blocker (ARB) and their dosage/administration is not changed within 2 weeks
Patients diagnosed with New York Heart Association (NYHA) class I to III
Patients with a left ventricular ejection fraction (LVEF) between 25% and 45%

Key exclusion criteria (4 listed)

Patients contraindicated for ß-blockers
Patients with occurrence of acute myocardial infarction within 2 weeks
Patients with unstable angina, coronary spastic angina, or angina at rest
Patients who have collected blood >400 mL within 4 months prior to screening or >200 mL within 1 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SK&F-105517-D 10 mg capsuleAlso: carvedilol phosphate1 capsule once a day	Drug	SK&F-105517-D group
Carvedilol-immediate release (IR) 2.5 mg tablet1 or 2 tablet(s) twice a day	Drug	Carvedilol-IR group
SK&F-105517-D 20 mg capsuleAlso: carvedilol phosphate1 capsule once a day	Drug	SK&F-105517-D group
SK&F-105517-D 40 mg capsuleAlso: carvedilol phosphate1 or 2 capsule(s) once a day	Drug	SK&F-105517-D group
Carvedilol-IR 10 mg tablet1 tablet twice a day	Drug	Carvedilol-IR group

Primary outcome

Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D)
Time frame: Treatment Period from Week 0 (Baseline) to Week 8 and 1-week Follow-up Period (Week 9) for CRV-IR; Treatment Period from Week 0 (Baseline) to Week 14 and 1-week Follow-up Period (Week 15) for SK&F-105517-D
Drug-related adverse events (AEs) were defined as AEs that were judged to have a relationship with the investigational product by the investigator (or subinvestigator) with the use of clinical judgment and the Clinical Investigator Brochure to determine the relationship. Refer to adverse event information for type and frequency of adverse events.
Mean Change From Baseline in Albumin and Total Protein at Week 8
Time frame: Baseline and Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Creatine Kinase, and Gamma Glutamyl Transferase at Week 8
Time frame: Baseline and Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Mean Change From Baseline in Amylase at Week 8
Time frame: Baseline and Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Mean Change From Baseline in Total Bilirubin, Creatinine, and Uric Acid at Week 8
Time frame: Baseline and Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Mean Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen at Week 8
Time frame: Baseline and Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Mean Change From Baseline in Creatine Kinase BB Percentage, Creatine Kinase MB Percentage, and Creatine Kinase MM Percentage at Week 8
Time frame: Baseline and Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value. (BB, brain-derived; MB=cardiac muscle-derived; MM=skeletal muscle-derived.
Mean Change From Baseline in Each Type of White Blood Cell (WBC) (Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils) at Week 8
Time frame: Baseline and Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Hemoglobin and Mean Corpuscular Hemoglobin Concentration at Week 8
Time frame: Baseline and Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Hematocrit at Week 8
Time frame: Baseline and Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Platelet Count and White Blood Cell Count at Week 8
Time frame: Baseline and Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Red Blood Cell Count at Week 8
Time frame: Baseline and Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Mean Corpuscular Hemoglobin at Week 8
Time frame: Baseline and Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Mean Corpuscular Volume at Week 8
Time frame: Baseline and Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Number of Participants With the Indicated Urinalysis Dipstick Results at Baseline and Week 8
Time frame: Baseline and Week 8
Dipstick test values: Negative (-), Traces (+-), +1, +2, +3. +4. Normal ranges (qualitative): protein, - or +-; glucose, - or +-; occult blood, -; ketones, -.
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 8
Time frame: Baseline and Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Heart Rate at Week 8
Time frame: Baseline and Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Weight at Week 8
Time frame: Baseline and Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Number of Participants With the Indicated Electrocardiogram Findings at Baseline and Week 8
Time frame: Baseline and Week 8
There are 3 categories for electrocardiogram (ECG) findings: normal; abnormal, not clinically significant; and abnormal, clinically significant. Each of the findings was classified by the investigator according to whether it was normal. Abnormal ECGs were further classified according to whether they were felt to be clinically significant in the medical and scientific judgment of the investigator.
Cardiothoracic Ratio at Baseline and Week 8
Time frame: Baseline and Week 8
Cardiothoracic ratio is a marker of the degree of heart enlargement and was measured by chest X-ray. It is shown as the ratio of the transverse diameter of the heart to the transverse diameter of the thorax, and is measured as a percentage.

9 secondary outcomes

Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8
Time frame: Week 8
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8
Time frame: Week 8
Time of Maximal Plasma Concentration (Tmax) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8
Time frame: Week 8
Adjusted Mean Change From Baseline in Systolic Blood Pressure at Week 8
Time frame: Baseline and Week 8
Adjusted Mean Change From Baseline in Diastolic Blood Pressure at Week 8
Time frame: Baseline and Week 8
Adjusted Mean Change From Baseline in Mean Heart Rate at Week 8
Time frame: Baseline and Week 8
Number of Participants With the Indicated Change From Baseline New York Heart Association (NYHA) Functional Class at Week 8
Time frame: Baseline and Week 8
Mean Plasma Brain Natriuretic Peptide Concentration at Baseline and Week 8
Time frame: Baseline and Week 8
Echocardiogram Results: Left Ventricular Ejection Fraction at Baseline and Week 8
Time frame: Baseline and Week 8

Results and safety

Results posted to the registry on 19 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CRV-IR	22	11
SK&F-105517-D	19	8

Primary outcome: Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D)

Time frame: Treatment Period from Week 0 (Baseline) to Week 8 and 1-week Follow-up Period (Week 9) for CRV-IR; Treatment Period from Week 0 (Baseline) to Week 14 and 1-week Follow-up Period (Week 15) for SK&F-105517-D. Number. Unit: participants

Measure	CRV-IR n = 22	SK&F-105517-D n = 19
Severe	0	1
Moderate	2	5
Mild	9	10
Severe (drug-related)	0	1
Moderate (drug-related)	2	3
Mild (drug-related)	3	4

Population analysed: Safety Population: all participants who received at least one dose of the investigational product

Primary outcome: Mean Change From Baseline in Albumin and Total Protein at Week 8

Time frame: Baseline and Week 8. Mean (Standard Deviation). Unit: grams per liter (g/L)

Measure	CRV-IR n = 22	SK&F-105517-D n = 19
Albumin	0.7 (2.87)	-1.9 (2.90)
Total Protein	0.4 (4.27)	-1.6 (4.72)

Population analysed: Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK\&F-105517-D group. Some participants in each treatment arm withdrew prematurely.

Primary outcome: Mean Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Creatine Kinase, and Gamma Glutamyl Transferase at Week 8

Time frame: Baseline and Week 8. Mean (Standard Deviation). Unit: international units per liter (IU/L)

Measure	CRV-IR n = 22	SK&F-105517-D n = 19
Alkaline Phosphatase	-10.9 (18.45)	-5.0 (21.13)
Alanine Aminotransferase	-0.2 (6.48)	3.8 (9.39)
Aspartate Aminotransferase	0.8 (3.87)	1.4 (7.19)
Creatine Kinase	34.4 (55.58)	-0.1 (65.54)
Gamma Glutamyl Transferase	-0.8 (3.68)	2.4 (10.62)

Primary outcome: Mean Change From Baseline in Amylase at Week 8

Time frame: Baseline and Week 8. Mean (Standard Deviation). Unit: units per liter (U/L)

Measure	CRV-IR n = 22	SK&F-105517-D n = 19
Value	-10.2 (9.98)	-0.1 (15.66)

9 secondary outcomes are reported in the full results.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
CRV-IR	1 of 22 (4.5%)	11 of 22 (50%)	Not reported
SK&F-105517-D	3 of 19 (15.8%)	15 of 19 (78.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22240593Kitakaze M, Sarai N, Ando H, Sakamoto T, Nakajima H. Safety and tolerability of once-daily controlled-release carvedilol 10-80 mg in Japanese patients with chronic heart failure. Circ J. 2012;76(3):668-74. doi: 10.1253/circj.cj-11-0210. Epub 2012 Jan 12.
Results for study 110734 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D) (time frame: Treatment Period from Week 0 (Baseline) to Week 8 and 1-week Follow-up Period (Week 9) for CRV-IR; Treatment Period from Week 0 (Baseline) to Week 14 and 1-week Follow-up Period (Week 15) for SK&F-105517-D). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00742508, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2017.