Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension
Status:
Completed
Trial end date:
2005-04-01
Target enrollment:
Participant gender:
Summary
The objective of this study is to evaluate efficacy, safety and tolerability of the
valsartan+amlodipine association in patients with mild to moderate essential hypertension, in
comparison to amlodipine alone.
Patients should have mild to moderate essential hypertension [grades 1 and 2 of WHO
classification (8)]. The diastolic blood pressure threshold for inclusion in this study is 95
mmHg, as these patients are more likely to benefit from association therapy than patients
with lower diastolic blood pressure.
For safety reasons, patients with severe hypertension (grade 3 of WHO classification) will
not be included in this study. Moreover, patients developing severe hypertension (MSDBP > 110
mmHg and/or MSSBP > 180 mmHg) during the open-label treatment phase will be discontinued from
the study.
Phase:
Phase 4
Details
Lead Sponsor:
Novartis
Treatments:
Amlodipine Amlodipine, Valsartan Drug Combination Valsartan