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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00171353
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: valsartan Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
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
Study Start Date : July 2004
Primary Completion Date : September 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

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

Arms and Interventions


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171353


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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171353     History of Changes
Other Study ID Numbers: CVAL489ARU01
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

Keywords provided by Novartis:
arterial hypertension
albuminuria
valsartan

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