Hypertension, PulmonaryPhase 2NCT00540436

Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension

A Phase 2 study testing GSK1325760A in people with Hypertension, Pulmonary, run by GlaxoSmithKline at 15 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 effect of GSK1325760A on improvement in exercise capacity in subjects with pulmonary arterial hypertension (PAH). The secondary objectives of this study are to evaluate administration of GSK1325760A on: The safety and tolerability Improvement of PAH The… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension, Pulmonary
What is being tested?: GSK1325760A
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 15 sitesJapan
Study dates: Aug 2007to Jan 2009
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must have a diagnosis of Pulmonary Arterial Hypertension (PAH) in clinical classification of Pulmonary Hypertension Group1
The mean right heart catheterization parameters measured from 6 months prior to the administration of the investigational drug must meet the criteria below:
Mean pulmonary arterial pressure (mPAP) of >25 mmHg
Pulmonary vascular resistance (PVR) of >3 mmHg/L/min
Mean pulmonary capillary wedge pressure or left ventricular end diastolic pressure of <15 mmHg (if measurable)
The measured six minutes walk distance (6MWD) at screening visit is in the range of =>150m and <=450m

Who cannot join

None listed.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Japan15 sites

GSK Investigational Site
Aichi, 470-1192
GSK Investigational Site
Fukuoka, 830-0011
GSK Investigational Site
Hokkaido, 060-8543
GSK Investigational Site
Hokkaido, 060-8648
GSK Investigational Site
Ishikawa, 920-8641
GSK Investigational Site
Kanagawa, 228-8555
GSK Investigational Site
Kyoto, 606-8507
GSK Investigational Site
Okayama, 701-1192
GSK Investigational Site
Okinawa, 901-0243
GSK Investigational Site
Osaka, 565-8565
GSK Investigational Site
Shizuoka, 431-3192
GSK Investigational Site
Tokyo, 113-8431
GSK Investigational Site
Tokyo, 113-8655
GSK Investigational Site
Tokyo, 143-8541
GSK Investigational Site
Tokyo, 160-8582

Other trials in Japan

About this study

Official title: Study AMB107816, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open-Label Phase II/III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A -<Classification: Exploratory and Confirmatory Clinical Trial>

The primary objective of this study is to evaluate the effect of GSK1325760A on improvement in exercise capacity in subjects with pulmonary arterial hypertension (PAH).

The secondary objectives of this study are to evaluate administration of GSK1325760A on:

The safety and tolerability
Improvement of PAH
The steady-state plasma pharmacokinetics of GSK1325760A

Conditions: Hypertension, Pulmonary
Being tested: GSK1325760A
Keywords: Ambrisentan, Pulmonary Arterial Hypertension, 6MWD
Medical subject headings: Hypertension, Pulmonary, Pulmonary Arterial Hypertension

What participants receive

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

GSK1325760ADrug
Also called Ambrisentan
Primary evaluation period: 5 mg/day, po, 12 weeks. Dose adjustment period: 2.5 mg, 5 mg or 10 mg/day, po, 12 weeks.

Study groups in NCT00540436
Study group	Role	What they receive
GSK1325760A	Experimental	Single arm safety and efficacy Receives: Drug: GSK1325760A

What is being measured

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

Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12
Mean change from baseline was calculated as the Week 12 value minus the baseline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes.
Measured: Baseline and Week 12

Secondary outcomes (9)

Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal
Change from baseline was calculated as the Week 24/Withdrawal value minus the basline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes. Imputation technique was last observation carried forward.
Measured: Baseline and Week 24/Withdrawal
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24
The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum). Change from baseline was calculated as the Week 12 and 24 values minus the baseline values. The BDI indicates the degree of breathlessness after completion of the 6 minute walk test. The BDI scale was assessed by each participant. Imputation technique was last observation carried forward.
Measured: Baseline and Weeks 12 and 24
Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24
There are four grades for WHO FC (class I = none, Class IV = most severe). The WHO FC indicates the severity of Pulmonary Arterial Hypertension and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. Imputation technique was last observation carried forward.
Measured: Weeks 12 and 24
Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) at Week 24, Assessed as the First Occurrence of a Particular Event
Time to clinical worsening is defined as the time from baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy, or study discontinuation due to change to other PAH treatment. Time to clinical worsening is measured as the number of participants who experienced these events during 24 weeks.
Measured: Week 24
Mean Change From Baseline in Mean Pulmonary Atery Pressure (mPAP) and Mean Right Atrial Pressure (mRAP) at Weeks 12 and 24
mPAP and mRAP are measures of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).
Measured: Baseline and Weeks 12 and 24
Mean Change From Baseline in Cardiac Index (CI) at Weeks 12 and 24
CI is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).
Measured: Baseline and Weeks 12 and 24
Mean Change From Baseline in Cardiac Output (CO) at Weeks 12 and 24
CO is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).
Measured: Baseline and Weeks 12 and 24
Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) at Weeks 12 and 24
PVR is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).
Measured: Baseline and Weeks 12 and 24
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 12 and 24
Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. BNP is a surrogate maker of heart failure and was measured by a central laboratory. Observed data analysis (no imputation techniques).
Measured: Baseline and Weeks 12 and 24

Timeline

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

Aug 2007Jan 2009

First posted8 Oct 2007 (estimated)
Study startAug 2007
Primary completionJan 2009
Study completionJan 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 Hypertension, PulmonaryStudies 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00540436
Sponsor's protocol ID: AMB107816
Status last verified: Oct 2012
First submitted: 5 Oct 2007
Last updated: 15 Oct 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

Yoshida S, Shirato K, Shimamura R, Nakahara N, Iwase T, Nakajima H. Efficacy, safety, and pharmacokinetics of ambrisentan in Japanese adults with pulmonary arterial hypertension. Curr Med Res Opin. 2011 Sep;27(9):1827-34. doi: 10.1185/03007995.2011.605440. Epub 2011 Aug 4.
PubMed 21812736

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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A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
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All Hypertension, Pulmonary trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study AMB107816, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open-Label Phase II/III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A -<Classification: Exploratory and Confirmatory Clinical Trial>
ClinicalTrials.gov ID: NCT00540436
Acronym / sponsor ID: AMB107816
Conditions: Hypertension, Pulmonary
Keywords: Ambrisentan, Pulmonary Arterial Hypertension, 6MWD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 8 Oct 2007 (estimated)
Results: Posted 10 Nov 2009

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 effect of GSK1325760A on improvement in exercise capacity in subjects with pulmonary arterial hypertension (PAH).

The secondary objectives of this study are to evaluate administration of GSK1325760A on:

The safety and tolerability
Improvement of PAH
The steady-state plasma pharmacokinetics of GSK1325760A

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GSK1325760A	Experimental	Drug: GSK1325760ASingle arm safety and efficacy

Who may qualify

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

Key inclusion criteria (6 listed)

Subjects must have a diagnosis of Pulmonary Arterial Hypertension (PAH) in clinical classification of Pulmonary Hypertension Group1
The mean right heart catheterization parameters measured from 6 months prior to the administration of the investigational drug must meet the criteria below:
Mean pulmonary arterial pressure (mPAP) of >25 mmHg
Pulmonary vascular resistance (PVR) of >3 mmHg/L/min
Mean pulmonary capillary wedge pressure or left ventricular end diastolic pressure of <15 mmHg (if measurable)

Key exclusion criteria (0 listed)

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
GSK1325760AAlso: AmbrisentanPrimary evaluation period: 5 mg/day, po, 12 weeks. Dose adjustment period: 2.5 mg, 5 mg or 10 mg/day, po, 12 weeks.	Drug	GSK1325760A

Primary outcome

Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12
Time frame: Baseline and Week 12
Mean change from baseline was calculated as the Week 12 value minus the baseline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes.

9 secondary outcomes

Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal
Time frame: Baseline and Week 24/Withdrawal
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24
Time frame: Baseline and Weeks 12 and 24
Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24
Time frame: Weeks 12 and 24
Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) at Week 24, Assessed as the First Occurrence of a Particular Event
Time frame: Week 24
Mean Change From Baseline in Mean Pulmonary Atery Pressure (mPAP) and Mean Right Atrial Pressure (mRAP) at Weeks 12 and 24
Time frame: Baseline and Weeks 12 and 24
Mean Change From Baseline in Cardiac Index (CI) at Weeks 12 and 24
Time frame: Baseline and Weeks 12 and 24
Mean Change From Baseline in Cardiac Output (CO) at Weeks 12 and 24
Time frame: Baseline and Weeks 12 and 24
Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) at Weeks 12 and 24
Time frame: Baseline and Weeks 12 and 24
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 12 and 24
Time frame: Baseline and Weeks 12 and 24

Results and safety

Results posted to the registry on 10 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK1325760A	25	22

Primary outcome: Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: Meters

Measure	GSK1325760A n = 25
Value	33.49 (43.236)

GSK1325760A: Mean change: 33.49 (95% CI 15.231 to 51.744)

Population analysed: Full Analysis Set (FAS): all participants registered, with the exception of those who had not received any dose of the investigational product and those who had no efficacy assessment after administration of the investigational product. Imputation technique was last observation carried forward.

9 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
GSK1325760A	4 of ?	24 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21812736Yoshida S, Shirato K, Shimamura R, Nakahara N, Iwase T, Nakajima H. Efficacy, safety, and pharmacokinetics of ambrisentan in Japanese adults with pulmonary arterial hypertension. Curr Med Res Opin. 2011 Sep;27(9):1827-34. doi: 10.1185/03007995.2011.605440. Epub 2011 Aug 4.

Related trials for Hypertension, Pulmonary

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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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
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Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK1325760A in people with Hypertension, Pulmonary, run by GlaxoSmithKline at 15 sites in Japan.

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 6 inclusion and 0 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 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 10 Nov 2009). 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?

Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12 (time frame: Baseline and Week 12). 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 NCT00540436, 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 15 Oct 2012.