Ignite Creation Date:
2024-05-06 @ 7:49 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02603809
Status:
COMPLETED
Last Update Posted:
2022-11-23
First Post:
2015-11-09
Brief Title:
Dose-finding Study With ACT-132577 Aprocitentan in Participants With Essential Hypertension
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
A Multi-center Double-blind Double-dummy Randomized Placebo- and Active-reference Parallel Group Phase 2 Dose-finding Study With ACT-132577 in Subjects With Essential Hypertension Grade 1 and 2
Status:
COMPLETED
Status Verified Date:
2022-11
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:
The main objective will be to evaluate the dose-response of ACT-132577 aprocitentan on diastolic blood pressure DBP in participants with grade 1 or 2 essential hypertension
Secondary objectives will be to evaluate the dose-response of ACT-132577 on systolic blood pressure SBP control and response rate of blood pressure 24-hour ambulatory blood pressure monitoring ABPM and to evaluate the safety and tolerability of a once daily oral regimen of 4 doses of ACT-132577
Secondary objectives will be to evaluate the dose-response of ACT-132577 on systolic blood pressure SBP control and response rate of blood pressure 24-hour ambulatory blood pressure monitoring ABPM and to evaluate the safety and tolerability of a once daily oral regimen of 4 doses of ACT-132577
Detailed Description:
Participation in the study is planned to last up to 18 weeks A single-blind placebo run-in period of 4 to 6 weeks after which participants will be randomized into a double-blind treatment period of 8 weeks and a washout and follow-up period ending with an end-of-study visit approximately 12 weeks after randomization
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