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MK-0954E Study in Participants With Hypertension (MK-0954E-357)

NCT01302691 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2019-03-15

Study results available
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Summary

This study is being done to evaluate the efficacy, safety, and tolerability of losartan potassium 50 mg (L50) + hydrochlorothiazide 12.5 mg (H12.5) + amlodipine besylate 5 mg (A5) (MK-0954E). The primary hypothesis is that L50/H12.5/A5 is more effective in lowering mean trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to L50+A5 in Japanese participants with essential hypertension who are not adequately controlled following an 8-week treatment with filter period study drug (L50+A5).

Conditions

Interventions

DRUG

losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E)

One tablet, containing 50 mg losartan potassium, 12.5 mg hydrochlorothiazide, and 5 mg amlodipine besylate, orally, once daily, for 8 weeks.

DRUG

Losartan potassium

One tablet, containing 50 mg losartan potassium, orally, once daily, for 8 weeks.

DRUG

Amlodipine besylate

One capsule, containing 5 mg amlodipine besylate, orally, once daily, for 8 weeks.

DRUG

Placebo to MK-0954E

One tablet, containing placebo, orally, once daily, for 8 weeks.

DRUG

Placebo to losartan potassium

One tablet, containing placebo, orally, once daily, for 8 weeks.

DRUG

Placebo to amlodipine besylate

One capsule, containing placebo, orally, once daily, for 8 weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-01
Primary Completion
2012-04-01
Completion
2012-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01302691 on ClinicalTrials.gov