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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.
Information provided by (Responsible Party):
Novartis Identifier:
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: November 2011
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
Intervention Model: Single Group Assignment
Masking: None (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:

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)

Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All

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

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Please refer to this study by its identifier: NCT00171353

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

Responsible Party: Novartis Identifier: NCT00171353     History of Changes
Other Study ID Numbers: CVAL489ARU01
Study First Received: September 12, 2005
Last Updated: November 7, 2011

Keywords provided by Novartis:
arterial hypertension

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017