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The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy

NCT ID: NCT00666536

Last Updated: 2016-10-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

728 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Brief Summary

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The purpose of this trial is to compare blood pressure lowering efficacy of moderate Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 / 10 mg) in patients uncontrolled on ARB monotherapy, other than Valsartan

Detailed Description

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Conditions

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Hypertension

Keywords

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Hypertension adults Valsartan + Amlodipine Angiotensin Receptor Blockers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Aggressive treatment regimen (5/320 mg to 10/320 mg)

Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)

Group Type ACTIVE_COMPARATOR

valsartan and amlodipine

Intervention Type DRUG

Moderate treatment regimen (5/160 mg)

Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)

Group Type ACTIVE_COMPARATOR

valsartan and amlodipine

Intervention Type DRUG

Interventions

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valsartan and amlodipine

Intervention Type DRUG

valsartan and amlodipine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female outpatients
* 18 Years of age or older
* Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 150 mmHg and lower than 200 mmHg while on Angiotensin-Receptor Blocker monotherapy for a minimum period of 28 days prior to randomization

Exclusion Criteria

* Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 200 mmHg and/or Mean Sitting Diastolic Blood Pressure greater than or equal to 120 mmHg
* Transient ischemic attack (mini-stroke), myocardial infarction (heart attack), all types of revascularization procedures in the last 6 months
* Treatment with valsartan or any combination antihypertensive treatment with 28 days prior to screening (Visit 1)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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pharmaceuticals

Principal Investigators

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Suzanne Oparil, MD et al

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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Egan Healthcare

Metairie, Louisiana, United States

Site Status

Countries

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United States

References

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Oparil S, Giles T, Ofili EO, Pitt B, Seifu Y, Hilkert R, Samuel R, Sowers JR. Moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker monotherapy. J Hypertens. 2011 Jan;29(1):161-70. doi: 10.1097/HJH.0b013e32834000a7.

Reference Type RESULT
PMID: 21045734 (View on PubMed)

Giles TD, Oparil S, Ofili EO, Pitt B, Purkayastha D, Hilkert R, Samuel R, Sowers JR. The role of ambulatory blood pressure monitoring compared with clinic and home blood pressure measures in evaluating moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker monotherapy. Blood Press Monit. 2011 Apr;16(2):87-95. doi: 10.1097/MBP.0b013e328344c713.

Reference Type DERIVED
PMID: 21386706 (View on PubMed)

Other Identifiers

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CVAA489AUS02

Identifier Type: -

Identifier Source: org_study_id