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A 6-Week Multi-Center, Randomized, Double-Blind, Parallel Group Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension - Article


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Amlodipine and Benazepril

Lotrel 



Clinical Trial: A 6-Week Multi-Center, Randomized, Double-Blind, Parallel Group Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension

This study has been completed.

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00136851

Purpose

This trial is designed to study the efficacy of a amlodipine besylate/benazepril treatment regimen versus an amlodipine treatment regimen in the treatment of severe hypertension.
Condition Intervention Phase
Hypertension
  Drug: amlodipine besylate/benazepril hydrochloride
 Phase IV

MedlinePlus related topics:  High Blood Pressure

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 

Study start: December 2004

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both
Criteria

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 SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg and unresponsive to triple-drug regimens

Other protocol-defined exclusion criteria may apply.

Location Information


New Jersey
      Novartis Pharmaceuticals, East Hanover,  New Jersey,  07936,  United States

More Information

Study ID Numbers:  CCIB002FUS19
Last Updated:  August 26, 2005
Record first received:  August 26, 2005
ClinicalTrials.gov Identifier:  NCT00136851
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30


Source: ClinicalTrials.gov
Cache Date: August 31, 2005

Resources



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November 25, 2009


Page Updated: June 1, 2005
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