Hypertension
Conditions
Keywords
hypertension, valsartan
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
Interventions
DRUGvalsartan
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline diastolic blood pressure after 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed