Skip to main content
OpenTrials
Completed

NCT Number: NCT00136773

Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Albuminuria Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hypertension Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Amlodipine/benazepril

Drug

Primary outcomes

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

Secondary outcomes

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

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

  3. Change from baseline in insulin resistance after 52 weeks

  4. Change from baseline in urine albumin secretion after 52 weeks

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Aug 29, 2005
Registry last updated
Mar 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.