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A Study to Describe Vascular and Renal Effects and Safety of Valsartan in Patients With High Blood Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00171353
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

One hundred twenty patients with arterial hypertension and albuminuria (some amount of albumin in urine) are given valsartan 80 mg and then160 mg to normalize blood pressure. Hydrochlorothiazide (diuretic) 12.5-25 mg added if necessary.


Condition Intervention Phase
Hypertension
 Drug: valsartan
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Describe Vascular and Renal Effects and Safety of Valsartan 80 and 160 mg in Arterial Hypertension Patients

Resource links provided by NLM:

Drug Information available for: Valsartan
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in urine albumin excretion after 24 weeks
  • Change from baseline in an ultrasound measurement of blood flow after 24 weeks

Secondary Outcome Measures:
  • Effect of blood pressure changes on urine albumin excretion rate and blood vessel function

Enrollment: 109
Study Start Date: July 2004
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Arterial hypertension without previous regular treatment
  • Urinary albumin excretion rate above 30 mg / 24h
  • 30-65 years old

Exclusion Criteria:

  • Reno-vascular arterial hypertension
  • Therapy resistant edema
  • Chronic heart failure, angina pectoris
  • Diabetes mellitus

Other protocol-defined exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171353

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: NCT00171353     History of Changes
Other Study ID Numbers: CVAL489ARU01
Study First Received: September 12, 2005
Last Updated: November 7, 2011
Health Authority: Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Novartis:
arterial hypertension
albuminuria
valsartan

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013