Study to assess QCC374 in treatment of pulmonary arterial hypertension
Research type
Research Study
Full title
A randomized, parallel-group, placebo-controlled subject and investigator blinded study to assess the safety, tolerability, pharmacokinetics and efficacy of QCC374 in the treatment of pulmonary arterial hypertension
IRAS ID
216270
Contact name
Joanna Pepke-Zaba
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2016-001412-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 29 days
Research summary
This is a non-confirmatory, randomized, subject and investigator blinded, placebo controlled study of QCC374 in patients with Pulmonary Arterial Hypertension(PAH). The compound to be tested is part of a group of drugs called prostacyclins which are currently being used for the treatment of PAH. The study will have 2 parts.
In Part 1, an initial safety group, 8 subjects will be randomly split where 6 patients will receive the active drug (QCC374) and the remaining 2 will receive a placebo (like a sugar pill that does not contain any medications), the starting dose will be 0.03mg twice a day.
In Part 2, approximately 30 will be randomly split where 20 patients will receive the active drug (QCC374) and the remaining 10 will receive a placebo (like a sugar pill that does not contain any medications), with a planned starting dose of 0.06mg twice a day. In Parts 1 and 2, subjects will have their dose increased during the first two weeks of the study to 0.12mg twice a day, or to their highest dose patients can safely reach. The treatment duration is 16 weeks.
In the UK we will be looking at recruiting 6 patients across 2 sites.
The primary endpoint for this trial will be looking at how effective QCC374 can be on reducing the resistance of the pulmonary arteries. The main testes used in this study to check the resistance are: spirometry, Lung volume, 6-Minute Walk Test and right heart catheterisation.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
17/EE/0084
Date of REC Opinion
26 Apr 2017
REC opinion
Further Information Favourable Opinion