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A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00241137
First received: October 14, 2005
Last updated: November 22, 2011
Last verified: June 2006
History of Changes
  Purpose

The purpose of this was to evaluate valsartan 320mg compared to valsartan 160 mg in terms of blood pressure reduction in a patient population of mild to moderate hypertensives


Condition Intervention Phase
Hypertension
 Drug: valsartan
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg

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 diastolic blood pressure after 4 weeks

Secondary Outcome Measures:
  • Change from baseline systolic blood pressure after 4 weeks
  • Change from baseline diastolic and systolic blood pressure in patients with a diastolic blood pressure greater than or equal to 90 mmHg at randomization after 4 weeks
  • Adverse events and serious adverse events at each study visit for 4 weeks

Enrollment: 3790
Study Start Date: September 2003
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • Male or female age between 18-80 years of age, inclusive

    • Diagnosed at enrollment (visits 2) to be mild to moderate hypertensive with a MSDBP >= 95 and =< 109 mmHg for non treated patients.
    • Previously treated patients should have a MSDBP =< 109 mmHg at visit 1 and a MSDBP >= 95 and =< 109 mmHg at visit 2.
    • Written informed consent to participate in the study prior to any study procedures
    • Ability to communicate and comply with all study requirements

Exclusion Criteria:

  • Severe hypertension (grade 3 of WHO classification; >= 110 mmHg diastolic and/or >= 180 mmHg systolic).
  • Malignant hypertension
  • Inability to discontinue all prior anti-hypertensive medications safely for a period of 2 weeks, as required by the protocol.
  • Known history of proteinuria (greater than 0.3 gram per day)
  • Female patients who are not either post-menopausal for one year or surgically sterile, and who are not using effective contraceptive methods such as barrier method with spermicidal or an intra-uterine device. Oral contraceptive use is not allowed.
  • Known Keith-Wagener grade III or IV hypertensive retinopathy.
  • History of hypertensive encephalopathy or cerebrovascular accident at anytime prior to Visit 1.
  • Transient ischemic cerebral attack during the last 12 months prior to Visit 1.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241137

Locations
Germany
Investigative Centers, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceutical Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00241137     History of Changes
Other Study ID Numbers: CVAL489H2301
Study First Received: October 14, 2005
Last Updated: November 22, 2011
Health Authority: Canada: Health Canada

Keywords provided by Novartis:
hypertension
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 May 21, 2013