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

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00241137
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-14
• Study First Posted: 2005-10-18
• Status Verified: 2006-06
• Last Update Submitted: 2011-11-22
• Last Update Posted: 2011-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3790

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline diastolic blood pressure after 4 weeks

Secondary Outcome Measures

Name	Time	Method
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