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

October 14, 2005
November 22, 2011
September 2003
January 2005   (final data collection date for primary outcome measure)
Change from baseline diastolic blood pressure after 4 weeks
Not Provided
Complete list of historical versions of study NCT00241137 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
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A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg
A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension
Drug: valsartan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3790
January 2005
January 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00241137
CVAL489H2301
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceutical Novartis Pharmaceuticals
Novartis
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP