Ignite Creation Date:
2024-05-05 @ 9:12 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00832507
Status:
TERMINATED
Last Update Posted:
2014-02-04
First Post:
2009-01-29
Brief Title:
Study of Cicletanine for Pulmonary Arterial Hypertension PAH
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase 2 Randomized Double-blind Placebo-controlled Multicenter Dose-ranging Study of Cicletanine in Subjects With Pulmonary Arterial Hypertension
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 2 randomized double-blind placebo-controlled multicenter dose-ranging study will compare the efficacy safety and tolerability of cicletanine hydrochloride HCl to placebo in subjects with PAH Study drug will be administered alone or on the background of stable PAH therapy The study will consist of 3 periods a screening period a 12-week placebo-controlled treatment period and a long-term blinded extension period
Detailed Description:
The primary objective of this study is to compare the change in exercise capacity following treatment with cicletanine HCl or placebo in subjects with PAH
The secondary objectives of this study are
1 To compare the change in other clinical measures of PAH following treatment with cicletanine HCl or placebo in subjects with PAH
2 To compare the safety and tolerability of cicletanine HCl to placebo in subjects with PAH Additionally the long-term safety tolerability and efficacy of cicletanine HCl treatment will be evaluated
The secondary objectives of this study are
1 To compare the change in other clinical measures of PAH following treatment with cicletanine HCl or placebo in subjects with PAH
2 To compare the safety and tolerability of cicletanine HCl to placebo in subjects with PAH Additionally the long-term safety tolerability and efficacy of cicletanine HCl treatment will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None