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Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension

NCT ID: NCT00136851

Last Updated: 2011-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2005-07-31

Brief Summary

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This trial is designed to study the efficacy of an amlodipine besylate/benazepril treatment regimen versus an amlodipine treatment regimen in the treatment of severe hypertension.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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amlodipine besylate/benazepril hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of severe hypertension

Exclusion Criteria

* Diastolic blood pressure (DBP) \< 60 mm Hg
* Serum potassium \< 3.5 or \> 5.5 mEq/L in the absence of all potassium supplements
* Refractory hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or DBP ≥ 110 mmHg and unresponsive to triple-drug regimens
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Site Status

Countries

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United States

References

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Izzo JL Jr, Purkayastha D, Hall D, Hilkert RJ. Comparative efficacy and safety of amlodipine/benazepril combination therapy and amlodipine monotherapy in severe hypertension. J Hum Hypertens. 2010 Jun;24(6):403-9. doi: 10.1038/jhh.2009.80. Epub 2009 Nov 5.

Reference Type DERIVED
PMID: 19890370 (View on PubMed)

Other Identifiers

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CCIB002FUS19

Identifier Type: -

Identifier Source: org_study_id