NCT00367978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Dec 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2006

Completed
Last Updated

November 8, 2011

Status Verified

August 1, 2006

Enrollment Period

1.8 years

First QC Date

August 23, 2006

Last Update Submit

November 7, 2011

Conditions

Hypertension

Keywords

Hypertension, diabetes, African-American, amlodipine/benazepril

Outcome Measures

Primary Outcomes (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 Outcomes (5)

  • change from baseline in sitting diastolic BP at Week 24

  • change from baseline in sitting systolic BP at Week 24

  • change from baseline in urinary protein excretion at Week 24

  • change from baseline in HbA1c at Week 24

  • change from baseline in estimated glomerular filtration rate (EGFR) at Week 24

Interventions

Amlodipine/benazeprilDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

HypertensionDiabetes Mellitus

Interventions

benazepril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Novartis Pharmaceuticals Corporation

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2006

First Posted

August 24, 2006

Study Start

December 1, 2001

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

November 8, 2011

Record last verified: 2006-08

Locations

US(1)