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Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)

NCT01277822 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2024-06-20

Study results available
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Summary

This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.

Conditions

Interventions

DRUG

Losartan (+) amlodipine

One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks.

DRUG

Placebo to match losartan/amlodipine tablets

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

DRUG

Amlodipine camsylate

2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks.

DRUG

Placebo to match amlodipine

2 tablets containing placebo, orally, once daily, for 8 weeks.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-30
Primary Completion
2013-04-22
Completion
2013-04-22

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Entities

Diseases

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 NCT01277822 on ClinicalTrials.gov