Ignite Creation Date:
2024-05-05 @ 11:38 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01370655
Status:
COMPLETED
Last Update Posted:
2018-09-21
First Post:
2011-06-08
Brief Title:
A Study of MK-7145 Compared to Placebo and Hydrochlorothiazide for Lowering Blood Pressure in Male Participants With Hypertension MK-7145-009
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase Ib Randomized Double-Blind 4-Treatment 2-Period Incomplete Block Study to Evaluate the Multiple Dose Effects of MK-7145 and Hydrochlorothiazide Compared to Placebo on Blood Pressure in Male Patients With Hypertension
Status:
COMPLETED
Status Verified Date:
2018-08
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 study is being done to evaluate the antihypertensive efficacy and tolerability of MK-7145 in participants with mild-to-moderate hypertension
The primary hypotheses for the study were as follows
1 Multiple dose administration of 6-mg MK-7145 results in a reduction in systolic blood pressure SBP in male participants with mild to moderate hypertension that is superior to placebo as measured by time weighted average change from baseline over 24 hours postdose TWA0-24hrs on dosing Day 28
2 Multiple dose administration of 6-mg MK-7145 results in a reduction in SBP in male participants with mild to moderate hypertension that is similar to hydrochlorothiazide HCTZ as measured by TWA0-24hrs on dosing Day 28
3 The effect of MK-7145 and HCTZ on natriuresis UNaV as well as SBP and diastolic blood pressure DBP both as measured by TWA0-24hrs will be estimated
4 Multiple dose administration of MK-7145 for 4 weeks will be generally safe and well-tolerated
The primary hypotheses for the study were as follows
1 Multiple dose administration of 6-mg MK-7145 results in a reduction in systolic blood pressure SBP in male participants with mild to moderate hypertension that is superior to placebo as measured by time weighted average change from baseline over 24 hours postdose TWA0-24hrs on dosing Day 28
2 Multiple dose administration of 6-mg MK-7145 results in a reduction in SBP in male participants with mild to moderate hypertension that is similar to hydrochlorothiazide HCTZ as measured by TWA0-24hrs on dosing Day 28
3 The effect of MK-7145 and HCTZ on natriuresis UNaV as well as SBP and diastolic blood pressure DBP both as measured by TWA0-24hrs will be estimated
4 Multiple dose administration of MK-7145 for 4 weeks will be generally safe and well-tolerated
Detailed Description:
None
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