Status:
COMPLETED
A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- • 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
- 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.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
3790 Patients enrolled
Trial Details
Trial ID
NCT00241137
Start Date
September 1 2003
End Date
January 1 2005
Last Update
November 23 2011
Active Locations (1)
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1
Investigative Centers, Germany