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Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension | Clinical Trials | Clareo Health

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Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

An Open-label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Amlodipine 10 mg Plus Valsartan 160 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combination of an Angiotensin Receptor Blocker (Olmesartan 20 mg) Plus Amlodipine 10 mg

NCT00523744•Novartis

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).

Detailed Description

Title of study extension: An open-label, multicenter extension to evaluate the efficacy and tolerability of a 4 week therapy with hydrochlorothiazide 12.5 mg plus amlodipine 10 mg/valsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of olmesartan 20 mg plus amlodipine 10 mg followed by amlodipine 10 mg/valsartan 160 mg

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients (\>=18 years)
•Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods
•Patients with essential hypertension (diastolic blood pressure \>=100 mmHg and \<110 mmHg)
•\- Patients had to have a msSBP \>= 140 mmHg and/or msDBP \>= 90 mmHg at week 8 ie, end of core study.

Exclusion Criteria

•Severe hypertension (diastolic blood pressure \>=110 mmHg or systolic blood pressure \>= 180 mmHg)
•Pregnant or nursing women
•Treated hypertensive patients with controlled hypertension under current therapy
•A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
•prematurely discontinued the core study
•failed to comply with the core study protocol

Locations (2)

Novartis Investigative Site, , Germany

Schwerin, Germany

30 sites in Germany

Key Dates

Start Date

July 1, 2007

Primary Completion Date

December 1, 2007

Completion Date

December 1, 2007

Last Updated

August 4, 2020

Enrollment

257

ACTUAL participants

Conditions

Hypertension

Interventions

Amlodipine

DRUG

Olmesartan medoxomil

DRUG

Amlodipine+valsartan

DRUG

Hydrochlorothiazide

DRUG

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RECRUITING

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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: August 4, 2020Data 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.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

Inclusion Criteria

Exclusion Criteria

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