Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Hypertension
Intervention: Valsartan + Amlodipine besilate (Drug)
Phase: Phase 2/Phase 3
Sponsored by: Novartis
Official(s) and/or principal investigator(s):
Novartis Japan, Study Chair, Affiliation: Sponsor
The purpose of this study is to evaluate the safety and efficacy of fixed combination of
valsartan (40 mg and 80 mg) and amlodipine (2. 5 mg and 5 mg), valsartan and amlodipine alone,
and placebo in reducing blood pressure. The study will investigate the dose response
relationship for the combinations, monotherapies and placebo.
Official title: A Multi-Center, Factorial Study to Evaluate the Efficacy and Safety of 8-Week Treatment With VAA489 [Valsartan (40 and 80 mg) and Amlodipine (2.5 and 5 mg) Combined] and Alone in Essential Hypertensive Patients - Double-Blind Study of VAA489 in Patients With Essential Hypertension (Factorial Study)
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in mean sitting diastolic blood pressure at 8 weeks.
Change from baseline in mean sitting systolic blood pressure (MSSBP) at trough at 8 weeks.
Responder rate for achieving MSDBP < 90 mmHg or a ≥ 10 mmHg decrease compared to baseline.
Diastolic control rate for achieving MSDBP < 90mmHg.
Blood pressure control rate for achieving MSDBP <90 mmHg and MSSBP <140 mmHg.
Minimum age: 20 Years.
Maximum age: 80 Years.
- Essential hypertension
- Secondary hypertension or suspected of having secondary hypertension.
- A history of malignant hypertension
- Severe hypertension
- Significant heart, renal, hepatic diseases or significant cerebrovascular disorder
Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Novartis Pharmaceuticals, Tokyo 11111, Japan
Starting date: November 2006
Ending date: May 2008
Last updated: June 9, 2008