Ignite Creation Date:
2024-05-06 @ 1:04 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03924154
Status:
TERMINATED
Last Update Posted:
2020-03-09
First Post:
2019-04-05
Brief Title:
A Study of RVT-1201 in Patients With Pulmonary Arterial Hypertension ELEVATE 1
Sponsor:
Altavant Sciences GmbH
Organization:
Altavant Sciences GmbH
Study Overview
Official Title:
A Phase 2a Double-Blind Placebo-Controlled Multicenter Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamic Effects of RVT-1201 in Patients With Pulmonary Arterial Hypertension
Status:
TERMINATED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inability to enroll
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an exploratory Phase 2a randomized double-blind placebo-controlled parallel-group multicenter study to evaluate the safety tolerability pharmacokinetics and pharmacodynamic effects of RVT-1201 in patients with pulmonary arterial hypertension PAH
Detailed Description:
This is an exploratory Phase 2a randomized double-blind placebo-controlled parallel-group multicenter study to evaluate the safety tolerability pharmacokinetics and pharmacodynamic effects of RVT-1201 in patients with pulmonary arterial hypertension PAH
Study participation for each patient will last approximately 3 months and will consist of a screening period up to 28 days in duration a baseline period day 1 pre-dose a 6-week treatment period and a 2-week follow-up period
The study will enroll approximately 36 patients at approximately 20 centers across the United States and Canada
Study participation for each patient will last approximately 3 months and will consist of a screening period up to 28 days in duration a baseline period day 1 pre-dose a 6-week treatment period and a 2-week follow-up period
The study will enroll approximately 36 patients at approximately 20 centers across the United States and Canada
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None