NCT00540436 is a Phase 2 clinical trial of GSK1325760A in Hypertension, Pulmonary, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00540436?

NCT00540436 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00540436?

Interventions in NCT00540436: GSK1325760A.

What condition does NCT00540436 study?

NCT00540436 studies Hypertension, Pulmonary.

Is NCT00540436 still recruiting?

NCT00540436 is currently completed. Last updated 11 October 2012.

Are results published for NCT00540436?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2012-10-11 · How we verify

NCT00540436

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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>

Completed Phase 2 Results posted Last updated 11 October 2012

What this trial tests

Phase 2 trial testing GSK1325760A in Hypertension, Pulmonary in 25 participants. Completed in 1 January 2009.

Timeline

1 August 2007

Primary endpoint
1 January 2009

1 January 2009

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	1 August 2007
Primary completion	1 January 2009
Estimated completion	1 January 2009
Sites	15 locations across Japan

Drugs / interventions tested

GSK1325760A — full drug profile →

Conditions studied

Hypertension, Pulmonary — all drugs for Hypertension, Pulmonary →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with 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.

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.

Sponsor's own description

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

Publications & conference data

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

Efficacy, safety, and pharmacokinetics of ambrisentan in Japanese adults with pulmonary arterial hypertension.
Yoshida S, Shirato K, Shimamura R, Nakahara N, et al · · 2011 · cited 10× · PMID 21812736 · DOI 10.1185/03007995.2011.605440

Verify or expand the search:

Other recruiting trials for Hypertension, Pulmonary

Currently open trials in the same condition.

NCT07087613 — Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG · recruiting
NCT06814145 — Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023) · Phase 2 · recruiting
NCT05867914 — Early Feasibility Study Evaluating the 3P-100 Device in Subjects With PH-ILD · NA · active not recruiting
NCT05719415 — Functional Pulmonary Capillary Surface Area in BPA for CTEPH · NA · recruiting
NCT05179876 — A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no O · Phase 3 · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00540436 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 11 October 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00540436.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing