HypertensionPhase 3NCT00273052

COREG MR Versus TOPROL-XL On The Lipid Profile Of Normolipidemic Or Mildly Dyslipidemic Patients With Hypertension

A Phase 3 study testing Carvedilol Phosphate modified release formulation and metoprolol succinate in people with Hypertension, run by GlaxoSmithKline at 120 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

This study was designed to determine whether treatment with COREG MR is more effective at maintaining a better lipid profile than treatment with TOPROL-XL for hypertension. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hypertension
What is being tested?: Carvedilol Phosphate modified release formulation and metoprolol succinate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 514 participants
Where: 120 sitesin 3 countries
Study dates: 5 Jan 2006to 28 Dec 2007
Phase: Phase 3
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Documented history of hypertension
Triglycerides of 120-400 mg/mL
LDLc levels not requiring lipid lowering medication.

Who cannot join

Has known contraindication to alpha- or beta-blocker therapy.
Has taken any non-ocular beta-blockers within three months before screening.
Has Type I or II diabetes.
Taking lipid lowering medications.

Trial locations and contacts

120 sites in 3 countries.

Country

City, postcode or hospital

120 sites in 3 countries

United States102 sites

GSK Investigational Site
Albuquerque, New Mexico, 87102
GSK Investigational Site
Albuquerque, New Mexico, 87108
GSK Investigational Site
Altamonte Springs, Florida, 32714
GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Auburn, Maine, 04210
GSK Investigational Site
Aurora, Illinois, 60504
GSK Investigational Site
Avon, Connecticut, 06001
GSK Investigational Site
Birmingham, Alabama, 35205
GSK Investigational Site
Birmingham, Alabama, 35209
GSK Investigational Site
Birmingham, Alabama, 35211
GSK Investigational Site
Birmingham, Alabama, 35242
GSK Investigational Site
Bossier City, Louisiana, 71111
GSK Investigational Site
Brick, New Jersey, 08724
GSK Investigational Site
Bristol, Tennessee, 37620
GSK Investigational Site
Brooklyn Center, Minnesota, 55430
GSK Investigational Site
Burke, Virginia, 22015
GSK Investigational Site
Carmichael, California, 95608
GSK Investigational Site
Chandler, Arizona, 85224
GSK Investigational Site
Charlotte, North Carolina, 28207
GSK Investigational Site
Chicago, Illinois, 60611
GSK Investigational Site
Cincinnati, Ohio, 45245
GSK Investigational Site
Cincinnati, Ohio, 45246
GSK Investigational Site
Clearwater, Florida, 33755
GSK Investigational Site
Cleveland, Ohio, 44195
GSK Investigational Site
Columbia, South Carolina, 29201
GSK Investigational Site
Corpus Christi, Texas, 78404
GSK Investigational Site
Detroit, Michigan, 48235
GSK Investigational Site
East Syracuse, New York, 13057
GSK Investigational Site
Elizabeth, New Jersey, 07202
GSK Investigational Site
Endwell, New York, 13760
GSK Investigational Site
Erie, Pennsylvania, 16508
GSK Investigational Site
Evansville, Indiana, 47714
GSK Investigational Site
Fayetteville, Arkansas, 72701
GSK Investigational Site
Fishkill, New York, 12524
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Galax, Virginia, 24333
GSK Investigational Site
Gillespie, Illinois, 62033
GSK Investigational Site
Greer, South Carolina, 29651
GSK Investigational Site
Hartsville, South Carolina, 29550
GSK Investigational Site
Healdsburg, California, 95448
GSK Investigational Site
Henderson, Nevada, 89014
GSK Investigational Site
Indianapolis, Indiana, 46260
GSK Investigational Site
Irvine, California, 92618
GSK Investigational Site
Jacksonville, Florida, 32205
GSK Investigational Site
Jacksonville, Florida, 32216
GSK Investigational Site
Jacksonville, Florida, 32259
GSK Investigational Site
Kettering, Ohio, 45429
GSK Investigational Site
Kingsport, Tennessee, 37660
GSK Investigational Site
La Jolla, California, 92037
GSK Investigational Site
Las Vegas, Nevada, 89119
GSK Investigational Site
Las Vegas, Nevada, 89128
GSK Investigational Site
Lewisburg, West Virginia, 24901
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Los Angeles, California, 90057
GSK Investigational Site
Los Angeles, California, 90502
GSK Investigational Site
Manassas, Virginia, 22015
GSK Investigational Site
Marietta, Georgia, 30067
GSK Investigational Site
Mesa, Arizona, 85201
GSK Investigational Site
Mission Viejo, California, 92691
GSK Investigational Site
Montgomery, Alabama, 36106
GSK Investigational Site
Natick, Massachusetts, 01760
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
Newport News, Virginia, 23606
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Olive Branch, Mississippi, 38654
GSK Investigational Site
Omaha, Nebraska, 68134
GSK Investigational Site
Omaha, Nebraska, 68144
GSK Investigational Site
Pembroke Pines, Florida, 33024
GSK Investigational Site
Phoenix, Arizona, 85014
GSK Investigational Site
Phoenix, Arizona, 85029
GSK Investigational Site
Poway, California, 92064
GSK Investigational Site
Raleigh, North Carolina, 27612
GSK Investigational Site
Richmond, Virginia, 23294
GSK Investigational Site
Roswell, Georgia, 30076
GSK Investigational Site
Sacramento, California, 95816
GSK Investigational Site
Salt Lake City, Utah, 84109
GSK Investigational Site
San Antonio, Texas, 78237
GSK Investigational Site
San Antonio, Texas, 78258
GSK Investigational Site
San Diego, California, 92177
GSK Investigational Site
Simpsonville, South Carolina, 29681
GSK Investigational Site
Spring Valley, California, 91978
GSK Investigational Site
Springfield, Missouri, 65807
GSK Investigational Site
Springfield, Virginia, 22151
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Statesville, North Carolina, 28625
GSK Investigational Site
Stockton, California, 95204
GSK Investigational Site
Taunton, Massachusetts, 02780.
GSK Investigational Site
Torrance, California, 90503
GSK Investigational Site
Tucson, Arizona, 85723
GSK Investigational Site
Tucson, Arizona, 85741
GSK Investigational Site
Vernon Hills, Illinois, 60061
GSK Investigational Site
Virginia Beach, Virginia, 23451
GSK Investigational Site
Vista, California, 92084
GSK Investigational Site
Walla Walla, Washington, 99362
GSK Investigational Site
Warminster, Pennsylvania, 18974
GSK Investigational Site
West Chester, Pennsylvania, 19380
GSK Investigational Site
West Yarmouth, Massachusetts, 02673
GSK Investigational Site
Wichita, Kansas, 67205
GSK Investigational Site
Wichita, Kansas, 67214
GSK Investigational Site
Wilmington, North Carolina, 28401
GSK Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Canada15 sites

GSK Investigational Site
Brampton, Ontario, L6T 3T1
GSK Investigational Site
Calgary, Alberta, T2E 7C5
GSK Investigational Site
Calgary, Alberta, T3C 3P1
GSK Investigational Site
Edmonton, Alberta, T5A 4L8
GSK Investigational Site
Gatineau, Quebec, J8Y 6S8
GSK Investigational Site
Greater Sudbury, Ontario, P3C 5K7
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5
GSK Investigational Site
London, Ontario, N5W 6A2
GSK Investigational Site
Mirabel, Quebec, J7J 2K8
GSK Investigational Site
Newmarket, Ontario, L3Y 5G8
GSK Investigational Site
Peterborough, Ontario, K9J 7B3
GSK Investigational Site
Sarnia, Ontario, N7T 4X3
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1E 2E2
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2

Other trials in Canada

Puerto Rico3 sites

GSK Investigational Site
Ponce, 731
GSK Investigational Site
Rio Grande, 00745
GSK Investigational Site
Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Carvedilol Phosphate Modified Release Formulation (COREG- MR) With Metoprolol Succinate (TOPROL XL) on the Lipid Profile in Normolipidemic, or Mildly Dyslipidemic Hypertensive Patients

This study was designed to determine whether treatment with COREG MR is more effective at maintaining a better lipid profile than treatment with TOPROL-XL for hypertension.

Conditions: Hypertension
Being tested: Carvedilol Phosphate modified release formulation, metoprolol succinate
Keywords: hypertension
Medical subject headings: Hypertension

What participants receive

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

Carvedilol Phosphate modified release formulationDrug
metoprolol succinateDrug
Also called Carvedilol Phosphate modified release formulation

Study groups in NCT00273052
Study group	Role	What they receive
Carvedilol Phosphate modified release formulation	Experimental	Not described Receives: Drug: Carvedilol Phosphate modified release formulation
metoprolol succinate	Active comparator	Not described Receives: Drug: metoprolol succinate

What is being measured

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

Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6
Blood draw for triglyceride levels. Full beta quantification test performed which uses ultracentrifugation to partially separate lipoprotein classes and is the basis for the reference methods. Change = Month 6 value minus Baseline value.
Measured: Baseline and Month 6
Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6
Blood draw for HDL-C levels. Full beta Quant test performed with HDL subclasses. Change = Month 6 value minus Baseline value.
Measured: Baseline and Month 6

Secondary outcomes (12)

Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6
Blood draw for hs-CRP. Change = Month 6 value minus Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6
Blood draw for LpPLA2 activity. Change = Month 6 value minus Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6
Manual physical examination (cuff blood pressure). Change = Month 6 value minus Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6
Manual physical examination. Change = Month 6 value minus Baseline value. (BPM=beats per minute)
Measured: Baseline and Month 6
Change From Baseline in Weight by Treatment Group at Maintenance Month
Manual physical examination. Change = Month 6 value minus Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6
Blood draw for lipid levels. Full beta Quant test performed with HDL subclasses and IDL. IDL=Intermediate density lipoproteins, LDL=Low-density lipoprotein, VLDL=Very Low density lipoprotein, HDL=High-density lipoprotein. Change = Month 6 value minus Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6
Blood draw for lipid levels. Full beta Quant test performed. Change = Month 6 value minus Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6
Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6
Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.
Measured: Baseline and Month 6
Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6
Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6
Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.
Measured: Baseline and Month 6
Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6
Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.
Measured: Baseline and Month 6

Timeline

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

5 Jan 200628 Dec 2007

First posted9 Jan 2006 (estimated)
Study start5 Jan 2006
Primary completion1 Dec 2007
Study completion28 Dec 2007

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.
Other trials for HypertensionStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 514 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00273052
Sponsor's protocol ID: COR103561
Status last verified: Mar 2018
First submitted: 5 Jan 2006
Last updated: 25 Jun 2018
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.

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?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Carvedilol Phosphate Modified Release Formulation (COREG- MR) With Metoprolol Succinate (TOPROL XL) on the Lipid Profile in Normolipidemic, or Mildly Dyslipidemic Hypertensive Patients
ClinicalTrials.gov ID: NCT00273052
Acronym / sponsor ID: COR103561
Conditions: Hypertension
Keywords: hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 514 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 5 Jan 2006
Primary completion: 1 Dec 2007 (actual)
Study completion: 28 Dec 2007 (actual)
First posted: 9 Jan 2006 (estimated)
Results: Posted 1 Feb 2010

Clinical summary

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

This study was designed to determine whether treatment with COREG MR is more effective at maintaining a better lipid profile than treatment with TOPROL-XL for hypertension.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Carvedilol Phosphate modified release formulation	Experimental	Drug: Carvedilol Phosphate modified release formulation
metoprolol succinate	Active comparator	Drug: metoprolol succinate

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Documented history of hypertension
Triglycerides of 120-400 mg/mL
LDLc levels not requiring lipid lowering medication.

Key exclusion criteria (4 listed)

Has known contraindication to alpha- or beta-blocker therapy.
Has taken any non-ocular beta-blockers within three months before screening.
Has Type I or II diabetes.
Taking lipid lowering medications.

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
Carvedilol Phosphate modified release formulation	Drug	Carvedilol Phosphate modified release formulation
metoprolol succinateAlso: Carvedilol Phosphate modified release formulation	Drug	metoprolol succinate

Primary outcome

Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6
Time frame: Baseline and Month 6
Blood draw for triglyceride levels. Full beta quantification test performed which uses ultracentrifugation to partially separate lipoprotein classes and is the basis for the reference methods. Change = Month 6 value minus Baseline value.
Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6
Time frame: Baseline and Month 6
Blood draw for HDL-C levels. Full beta Quant test performed with HDL subclasses. Change = Month 6 value minus Baseline value.

12 secondary outcomes

Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6
Time frame: Baseline and Month 6
Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6
Time frame: Baseline and Month 6
Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6
Time frame: Baseline and Month 6
Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6
Time frame: Baseline and Month 6
Change From Baseline in Weight by Treatment Group at Maintenance Month
Time frame: Baseline and Month 6
Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6
Time frame: Baseline and Month 6
Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6
Time frame: Baseline and Month 6
Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6
Time frame: Baseline and Month 6
Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6
Time frame: Baseline and Month 6
Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6
Time frame: Baseline and Month 6
Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6
Time frame: Baseline and Month 6
Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6
Time frame: Baseline and Month 6

Results and safety

Results posted to the registry on 1 Feb 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
Coreg CR	290	221
Toprol XL	278	190

Primary outcome: Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6

Time frame: Baseline and Month 6. Number. Unit: mg/dL

Measure	Coreg CR n = 235	Toprol XL n = 206
Value	2.65	10.39

Coreg CR vs Toprol XL: Median Difference (Net): -8.026 (95% CI -15.35 to -0.67), p = 0.0141, ANCOVA

Population analysed: The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).

Primary outcome: Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6

Time frame: Baseline and Month 6. Number. Unit: mg/dL

Measure	Coreg CR n = 235	Toprol XL n = 206
Value	-4.4	-5.1

Coreg CR vs Toprol XL: Mean Difference (Net): 0.7 (95% CI -2.4 to 3.9), p = 0.6068, ANCOVA

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Coreg CR	8 of ?	186 of ?	Not reported
Toprol XL	5 of ?	160 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
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Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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

120 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carvedilol Phosphate modified release formulation and metoprolol succinate in people with Hypertension, run by GlaxoSmithKline at 120 sites in 3 countries.

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 3 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 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Canada, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 1 Feb 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?

Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6 (time frame: Baseline and Month 6). The study lists 2 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 NCT00273052.

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 25 Jun 2018.