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Completed

NCT Number: NCT00540436

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

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

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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Hypertension Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

GSK1325760A

Drug

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

Other names: Ambrisentan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal

    Time frame: Baseline and 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.

  2. Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24

    Time frame: Baseline and 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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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).

  6. Mean Change From Baseline in Cardiac Index (CI) at Weeks 12 and 24

    Time frame: Baseline and 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).

  7. Mean Change From Baseline in Cardiac Output (CO) at Weeks 12 and 24

    Time frame: Baseline and 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).

  8. Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) at Weeks 12 and 24

    Time frame: Baseline and 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).

  9. Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 12 and 24

    Time frame: Baseline and 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).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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>

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 8, 2007
Registry last updated
Oct 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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