NCT00136773

Brief Summary

Type 2 diabetes mellitus is usually associated with high blood pressure, which is a risk factor for kidney disease. Aggressive blood pressure reduction is an important strategy to protect the kidney and reduce urinary protein which develops with kidney disease. This study will evaluate the effects of amlodipine/benazepril in reducing blood pressure and urinary protein in hypertensive subjects with type 2 diabetes mellitus.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
332

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2003

Typical duration for phase_4

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

March 9, 2011

Status Verified

March 1, 2008

Enrollment Period

2.5 years

First QC Date

August 25, 2005

Last Update Submit

March 8, 2011

Conditions

Albuminuria

Keywords

AlbuminuriaType 2 diabetes mellitusHypertension

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the urine albumin/creatinine ratio after 52 weeks

Secondary Outcomes (5)

  • Percentage of patients who have progressed to diabetic kidney disease (urine albumin/creatinine ratio ≥ 300 µg/mg creatinine) after 52 weeks

  • Change from baseline in the ratio of urine albumin/creatinine ratio an estimate of kidney function after 52 weeks

  • Change from baseline in insulin resistance after 52 weeks

  • Change from baseline in urine albumin secretion after 52 weeks

  • Change from baseline in a marker of heart failure after 52 weeks

Interventions

amlodipine/benazeprilDRUG

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild to moderate hypertension
  • Type 2 diabetes mellitus
  • Presence of protein in the urine (albuminuria)

You may not qualify if:

  • Kidney disease not caused by diabetes or hypertension
  • Renal artery stenosis
  • Myocardial infarction or stroke within the last 6 months
  • Type 1 diabetes mellitus
  • Pregnant or lactating females
  • Cancer within the last 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AlbuminuriaDiabetes Mellitus, Type 2Hypertension

Interventions

benazepril

Condition Hierarchy (Ancestors)

ProteinuriaUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

April 1, 2003

Primary Completion

October 1, 2005

Study Completion

November 1, 2005

Last Updated

March 9, 2011

Record last verified: 2008-03