A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: MK-954H; Drug: MK-0954A; Drug: Placebo to MK-0954A; Drug: Placebo to MK-954H

• Registration Number: NCT01307033
• Lead Sponsor: Organon and Co

Brief Summary

This study is being conducted to evaluate the safety of MK-0954A (L100/H12.5 mg) in essential hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).

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: 2012-12-04
• Study Completion: 2012-12-04
• Results First Submitted: 2013-11-14
• Results First Submitted QC: 2013-11-14
• Results First Posted: 2014-01-06
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK-954H (L50/H12.5)	Placebo to MK-0954A	One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
MK-0954A (L100/H12.5)	Placebo to MK-954H	One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
MK-954H (L50/H12.5)	MK-954H	One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
MK-0954A (L100/H12.5)	MK-0954A	One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension)	Up to 52 weeks

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8	Baseline and Week 8 (End of Double-blind Period)	Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.
Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8	Baseline and Week 8 (End of Double-blind Period)	Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.