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

This study has been completed.

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00241137
  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 III

MedlinePlus related topics:   High Blood Pressure   

ChemIDplus related topics:   Valsartan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:   A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg

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

Estimated Enrollment:   3236

  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


Study ID Numbers:   CVAL489H2301
First Received:   October 14, 2005
Last Updated:   November 13, 2006
ClinicalTrials.gov Identifier:   NCT00241137
Health Authority:   Canada: Health Canada

Keywords provided by Novartis:
hypertension  
valsartan  

Study placed in the following topic categories:
Vascular Diseases
Valsartan
Hypertension

Additional relevant MeSH terms:
Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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