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Effects of Amlodipine/Benazepril in the Hypertensive African-American Population With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00367978
Recruitment Status : Completed
First Posted : August 24, 2006
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study evaluated the efficacy and safety of amlodipine/benazepril compared with that of enalapril in the treatment of hypertension in African-American patients with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Amlodipine/benazepril Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Study to Determine the Efficacy and Safety of Amlodipine/Benazepril Hydrochloride Versus Enalapril in the Treatment of Hypertension in an African-American Population With Type 2 Diabetes
Study Start Date : December 2001
Primary Completion Date : September 2003
Study Completion Date : September 2003


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Time from baseline to the achievement of first treatment success (defined as achieving a blood pressure (BP) <130/80 mm Hg). The proportion and cumulative proportion of patients who achieved first treatment success were also determined.

Secondary Outcome Measures :
  1. change from baseline in sitting diastolic BP at Week 24
  2. change from baseline in sitting systolic BP at Week 24
  3. change from baseline in urinary protein excretion at Week 24
  4. change from baseline in HbA1c at Week 24
  5. change from baseline in estimated glomerular filtration rate (EGFR) at Week 24

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • African-American
  • males and females
  • current diagnosis of type 2 diabetes documented by medical history;
  • mean sitting diastolic blood pressure of ≥ 90 and ≤ 110 mm Hg;
  • HbA1C ≤ 9.5%

Exclusion Criteria:

  • having unilateral or bilateral renal artery stenosis;
  • having clinically significant cardiac dysrhythmias;
  • having a significant history of coronary artery disease within the past 6 months;
  • having a history or diagnosis of congestive heart failure (CHF);
  • having any clinically relevant cardiac valvular disease
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367978


Locations
United States, New Jersey
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Corporation Novartis Pharmaceuticals
More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00367978     History of Changes
Other Study ID Numbers: CCIB002FUS06
First Posted: August 24, 2006    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: August 2006

Keywords provided by Novartis:
Hypertension, diabetes, African-American, amlodipine/benazepril

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Benazepril
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors