MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: MK-0954A; Drug: Losartan; Drug: Placebo to MK-0954A; Drug: Placebo to losartan 100 mg; Drug: Placebo to losartan 50 mg

• Registration Number: NCT01307046
• Lead Sponsor: Organon and Co

Brief Summary

This study is being conducted to evaluate the efficacy of MK-0954A in essential hypertension participants who are not adequately controlled with losartan.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-01
• Study First Posted: 2011-03-02
• Study Start: 2011-03-29
• Primary Completion: 2012-02-07
• Study Completion: 2012-02-07
• Results First Submitted: 2013-01-02
• Results First Submitted QC: 2013-02-19
• Results First Posted: 2013-03-22
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK-0954A	MK-0954A	Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
Losartan	Placebo to MK-0954A	Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
MK-0954A	Placebo to losartan 100 mg	Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
MK-0954A	Placebo to losartan 50 mg	Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
Losartan	Placebo to losartan 50 mg	Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
Losartan	Losartan	Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experienced at Least One Adverse Event (AE)	8 weeks
Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)	Baseline and Week 8	Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)	Baseline and Week 8	Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).