To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; High Blood Pressure
Intervention: Amlodipine 5mg/Valsartan 80 mg (Drug); Valsartan (Drug)
Phase: Phase 4
Sponsored by: Novartis
Official(s) and/or principal investigator(s):
Novartis Novartis, Study Chair, Affiliation: Novartis
The purpose of the study was to assess efficacy and safety of fixed dose combination of 5 mg
amlodipine/80 mg valsartan compared to 160 mg valsartan monotherapy in lowering blood
pressure in Taiwanese patients.
Official title: A Single Center, Randomized, Double-blind, Active Controlled, Parallel Group Study to Demonstrate Non-inferiority of a Fixed Dose Combination of 5 mg Amlodipine and 80 mg Valsartan to 160 mg Valsartan in the Treatment of Hypertension
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement
Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours
Change From Baseline in Mean Diastolic Blood Pressure (mDBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours After 8 Weeks of Treatment During the Double-blind Phase
Number of Participants With Adverse Events During Double-blind Phase
Minimum age: 18 Years.
Maximum age: N/A.
- Participants over 18 years of age with hypertension defined as sitting systolic blood
pressure between 140 mmHg and 180 mmHg or sitting diastolic blood pressure between 90
mmHg and 120 mmHg.
- High risk participants ( defined as having: (diabetes mellitus, chronic renal
disease, Framingham 10-year risk score >10%, established coronary artery disease
(CAD), or CAD equivalents including carotid artery disease, peripheral arterial
disease (PAD), abdominal aortic aneurysm (AAA))with hypertension defined as sitting
systolic blood pressure between 130 mmHg and 180 mmHg or sitting diastolic blood
pressure between 80 mmHg and 120 mmHg.
- Known or suspected secondary hypertension
- Known New York Heart Association (NYHA) functional class IV Heart Failure
- History of myocardial infarction, transient ischemic attack or cerebrovascular
accident within the preceding 3 months
- Clinically significant valvular disease
- Women who are pregnant, intend to become pregnant or are breastfeeding
- Participants who have severe medical condition(s) that in the view of the
Investigator prohibits participation in the study
- Participants who have hypersensitivity to the investigational/ reference drug or any
of the components in the formulation.
- Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Taipei 11217, Taiwan
Starting date: June 2009
Last updated: September 13, 2011