At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled
Drug / intervention
GSK1325760Adrug
Likely dose
GSK1325760A 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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>
In Brief
A Phase 2 clinical trial evaluating GSK1325760A for Hypertension, Pulmonary. Completed, enrolled 25 participants across 15 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Pulmonary
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedOct 2007
Primary CompletionJan 2009
TodayJul 2026
First PostedOct 8, 2007
Enrollment StartAug 1, 2007
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.7 years ago
Interventions
GSK1325760Adrug
Primary evaluation period: 5 mg/day, po, 12 weeks. Dose adjustment period: 2.5 mg, 5 mg or 10 mg/day, po, 12 weeks.