Dose-ranging Study of Cicletanine in Subjects with PAH

• Research type

  Research Study

• Full title

  A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial Hypertension

• IRAS ID

  16914

• Contact name

  Gerry Coghlan

• Sponsor organisation

  Gilead Sciences

• Eudract number

  2008-007455-26

• Clinicaltrials.gov Identifier

  NCT00832507

• Research summary

  This phase 2, multicenter, double-blinded, randomized study is being conducted to investigate an experimental drug named cicletanine hydrochloride (??cicletanine?) for the treatment of pulmonary arterial hypertension (PAH). The purpose of this study is to see if treatment with cicletanine improves a patient??s ability to exercise better than treatment with placebo (a capsule that looks the same, but contains no medication) after 12 weeks of therapy. Patients exercise capacity will be calculated by measuring the distance they walk in a ??6-mintue walk test? that they will perform at the start of the study and again at Week 12. Several other measurements will be taken during this study to analyze whether cicletanine is effective in treating PAH. The safety of cicletanine, along with how a patient tolerates the medication, will also be analyzed. The study also includes a long-term extension study in which all subjects will be on active treatment. Safety, tolerability and efficacy will continue to be measured during the long-term extension period.A total of approximately 160 subjects from about 60 clinics in 11 countries will participate. Patients will continue to receive treatment until the physician, Sponsor, or regulatory authority terminates the study or the patient voluntarily decides to stop end his/her participation.This study is sponsored by Gilead Sciences, Inc

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  09/H0706/46

• Date of REC Opinion

  31 Dec 2009

• REC opinion

  Further Information Favourable Opinion