Phase 2
Completed N=25
Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension
Hypertension, Pulmonary
Source: ClinicalTrials.gov NCT00540436 ↗
Enrolled (actual)
25
Serious AEs
—
Results posted
Nov 2009
Primary outcomePrimary: Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12 — 33.49 Meters
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 steady-state plasma pharmacokinetics of GSK1325760A
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12 |
33.49 | — |
| SECONDARY Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal |
46.82 | — |
| SECONDARY Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24 |
-0.60; -0.69 | — |
| SECONDARY Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 |
9; 16; 0; 10; 14; 1 | — |
| SECONDARY 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 |
0; 0; 0; 0; 1 | — |
| SECONDARY Mean Change From Baseline in Mean Pulmonary Atery Pressure (mPAP) and Mean Right Atrial Pressure (mRAP) at Weeks 12 and 24 |
-6.29; -1.12; -8.69; -0.69 | — |
| SECONDARY Mean Change From Baseline in Cardiac Index (CI) at Weeks 12 and 24 |
0.623; 0.598 | — |
| SECONDARY Mean Change From Baseline in Cardiac Output (CO) at Weeks 12 and 24 |
1.033; 1.035 | — |
| SECONDARY Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) at Weeks 12 and 24 |
-7.257; -8.349 | — |
| SECONDARY Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 12 and 24 |
-76.86; -60.15 | — |
Eligibility Criteria
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 150m and <=450m
Data sourced from ClinicalTrials.gov (NCT00540436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.