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

COMPLETEDPHASE4

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

The 8 Weeks, Multicenter, Randomized, Double-blind, Clinical Study To Evaluate Efficacy Of Treatment With Losartan/Amlodipine 100/5 mg Combination Compared To Amlodipine 10 mg Monotherapy In Hypertensive Patients Who Are Not Appropriately Respond To Amlodipine 5 mg Monotherapy

NCT01277822•Organon and Co

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with essential hypertension:
•* who are on single drug therapy
•* who are newly diagnosed and not yet taking any drug therapy, or have not had any drug therapy for at least 2 weeks prior to entering study
•* who have blood pressure readings of 90mmHg ≤ MSDBP \< 110mmHg and 140mmHg ≤ MSSBP \<180mmHg after 2 weeks wash-out for patients on single agent.
•Randomization (Visit 3)
•* After dosing of amlodipine 5mg for 6 weeks, blood pressure readings are:
•* 90mmHg ≤ MSDBP \< 110mmHg and 140mmHg ≤ MSSBP \< 180mmHg.

Exclusion Criteria

•Participant with MSDBP ≥ 110mmHg or MSSBP ≥ 180mmHg.
•Participant currently taking ≥ 2 antihypertensive medications (note: fixed-dose combination medicine should be counted as the number of active ingredients).
•Participant with known secondary hypertension of any etiology.
•Participant with malignant hypertension or current evidence of impending or active malignant hypertension, including headache, papilledema, cardiac ischemia, or pulmonary congestion precipitated by elevated blood pressure.
•Participant with known intolerance, contraindication or hypersensitivity to any component of dihydropyridines, angiotensin II receptor blockers.
•Participant showing positive in pregnancy test, lactating woman, or woman who intends to get pregnant during the study period.

Key Dates

Start Date

May 30, 2011

Primary Completion Date

April 22, 2013

Completion Date

April 22, 2013

Last Updated

June 20, 2024

Enrollment

334

ACTUAL participants

Conditions

Hypertension

Interventions

Losartan (+) amlodipine

DRUG

Placebo to match losartan/amlodipine tablets

DRUG

Amlodipine camsylate

DRUG

Placebo to match amlodipine

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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