ROR-PH-302 - ADVANCE Capacity
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy
IRAS ID
269752
Contact name
Luke Howard
Contact email
Sponsor organisation
UNITED THERAPEUTICS CORPORATION
Eudract number
2019-003309-88
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 2 days
Research summary
The purpose of this study is to evaluate the effects of ralinepag therapy on exercise capacity obtained during cardiopulmonary exercise testing (CPET) after 28 weeks of treatment.
It is a multicentre study with approximately 50 participating study centres.
Approximately 193 participants will be randomised, to have 135 completers with both a valid Baseline and Week 28 cardiopulmonary exercise testing (CPET) assessment.
Total study duration is up to 36 weeks, including a Screening Period of up to 28 days in duration, a 28-week Treatment Period, and a 28-day Follow-up Period (for those who complete Week 28 on study drug but do not enrol in TDE-PH-303). Participants will receive treatment with study drug (ralinepag or placebo) for a total of up to 28 weeks.
Participants who have pulmonary arterial hypertension (PAH) will be invited to take part in this research study. This means that their blood vessels (pulmonary arteries) going from their heart to the lungs have higher than normal pressure. This puts a strain on their heart. This strain causes the heart to pump less blood into the lungs. This will result in symptoms like shortness of breath, tiredness, and swelling in the feet and stomach. Over time, these symptoms can get worse because the heart cannot pump enough blood into the lungs.
REC name
London - Westminster Research Ethics Committee
REC reference
20/LO/0345
Date of REC Opinion
2 Jun 2020
REC opinion
Further Information Favourable Opinion