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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00241137
First Posted: October 18, 2005
Last Update Posted: November 23, 2011
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.
Information provided by (Responsible Party):
Novartis
  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
Primary Purpose: Treatment
Official Title: A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00241137


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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00241137     History of Changes
Other Study ID Numbers: CVAL489H2301
First Submitted: October 14, 2005
First Posted: October 18, 2005
Last Update Posted: November 23, 2011
Last Verified: June 2006

Keywords provided by Novartis:
hypertension
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