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Valsartan/Hydrochlorothiazide Combination vs Amlodipine in Patients With Hypertension, Diabetes, and Albuminuria.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00171561
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

The purpose of this study is assess if treatment with valsartan and a diuretic, hydrochlorothiazide, has beneficial effects in people with high blood pressure, diabetes, and albuminuria (protein in the urine) compared with amlodipine. In particular, the study will assess whether the treatment will decrease the stiffness of the blood vessels.


Condition Intervention Phase
Hypertension
 Drug: valsartan/hydrochlorothiazide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 24-week Study to Evaluate the Effectiveness of Valsartan in Combination With Hydrochlorothiazide Versus Amlodipine on Arterial Compliance in Patients With Hypertension, Type 2 Diabetes and Albuminuria

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Blood measures of hypertension after 24 weeks

Secondary Outcome Measures:
  • Blood measures of hypertension in arterial system after 24 weeks
  • Change in protein excretion rate after 24 weeks
  • Change in serum markers of endothelial function and oxidative stress after 24 weeks

Enrollment: 144
Study Start Date: March 2003
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • type 2 diabetes
  • elevated blood pressure and pulse pressure
  • albuminuria

Exclusion Criteria:

  • Severe hypertension
  • History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
  • Liver, kidney (not caused by diabetes), or pancreas disease
  • Type 1 diabetes or uncontrolled type 2 diabetes
  • Allergy to certain medications used to treat high blood pressure

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171561

Locations
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171561     History of Changes
Other Study ID Numbers: CVAH631B2404
Study First Received: September 12, 2005
Last Updated: November 7, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by Novartis:
hypertension
diabetes
albuminuria
 valsartan
hydrochlorothiazide
amlodipine

Additional relevant MeSH terms:
Albuminuria
Hypertension
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Valsartan
Amlodipine
Diuretics
 Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 21, 2013