NCT00554619

Study AMB107818, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open Label Study of GSK1325760A to Evaluate the Safety and Efficacy of GSK1325760A - a Long-term Extension Study -

Completed Phase 3 Results posted Last updated 1 November 2012

What this trial tests

Phase 3 trial testing GSK1325760A in Pulmonary Arterial Hypertension in 21 participants. Completed in 1 January 2011.

Timeline

1 February 2008

Primary endpoint
1 January 2011

1 January 2011

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	1 February 2008
Primary completion	1 January 2011
Estimated completion	1 January 2011
Sites	11 locations across Japan

Drugs / interventions tested

• GSK1325760A — full drug profile →

Conditions studied

• Pulmonary Arterial Hypertension — all drugs for Pulmonary Arterial Hypertension →
• Hypertension, Pulmonary — all drugs for Hypertension, Pulmonary →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Eligibility, any sex, with Pulmonary Arterial Hypertension or Hypertension, Pulmonary. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants With Any Adverse Event
  Time frame: For 140.57 weeks at maximum, starting from Week 24
  An adverse event was defined as any untoward medical occurrence in a participant, temporally associated with the use of an investigational product, whether or not considered related to the investigational product.
• Number of Participants With Adverse Events Categorized by Severity
  Time frame: For 140.57 weeks at maximum, starting from Week 24
  The severity of adverse events was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal

Sponsor's own description

The primary objective of this study is to evaluate the safety of long-term administration of GSK1325760A in patients with PAH.

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

* Improvement in exercise capacity (six-minutes walk distance: 6MWD), change in WHO Functional Classification and time to clinical worsening of PAH
* Change in the Borg Dyspnea Index (assessed immediately following the six-minute walk test \[6MWT\])
* Change in plasma brain natriuretic peptide (BNP) levels
* Cardiopulmonary hemodynamics parameters (as measured by echocardiography)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Long-term safety and efficacy of ambrisentan in Japanese adults with pulmonary arterial hypertension.
   Yoshida S, Shirato K, Shimamura R, Iwase T, et al · · 2012 · cited 6× · PMID 22506623 · DOI 10.1185/03007995.2012.685930