2 doses of CXA-10, vs placebo, in Pulmonary Arterial Hypertension
Research type
Research Study
Full title
Phase 2 Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects with Pulmonary Arterial Hypertension (PAH)
IRAS ID
244109
Contact name
Luke Howard
Contact email
Sponsor organisation
Complexa Inc.
Eudract number
2018-000328-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
Patients with Pulmonary Arterial Hypertension (PAH) have high blood pressure in the blood vessels between their heart and lungs. These have become narrow, so the heart works harder, leading to a weakened heart. Patients are usually breathless on exertion, tired and can do less exercise. Noticeable symptoms of right heart failure show late in the disease. The 5-year survival rate for patients is 57%.
This study is in adult patients with PAH, who are already taking medication for this disease. It is to see whether a new study drug, called CXA-10, can help lower the pressure in the blood vessels from the heart to the lungs, can help improve heart health and to see if it is safe. The study will look at two different doses of CXA-10. The study is placebo-controlled, so some patients will receive a dummy pill.
The study will be conducted in the USA and in approximately 6 sites in the UK. The UK sites are PAH centres; suitable PAH patients who are being treated at the sites will be invited to take part.
Each patient will be on the study for about 5 months. The study has three periods:
• Screening Period: To check a patient qualifies for the study (lasts up to 30 days).
• Study Drug Period: 90 days; 1 tablet will be taken daily.
• Follow-Up Period: About 14 days after the last dose of study drug, to check that patients are doing fine.There are seven clinic visits and up to four other visits by phone. 5 visits are over-night fasted. Procedures will include two right heart catheterisations, two cardiac MRIs, walking distance checks, multiple blood draws every visit, ECGs, vital signs, physicals, urine samples, questionnaire completion, and blood oxygen. Medical history will be taken. Patients will wear an activity monitor.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0392
Date of REC Opinion
19 Oct 2018
REC opinion
Further Information Favourable Opinion