Clinical trial NCT01070043: To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
High Blood Pressure
Keywords: Hypertension
valsartan
amlodipine
high blood pressure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement
timeFrame: Baseline and 8 weeks
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours
timeFrame: Baseline and 8 weeks
measure: 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
timeFrame: Baseline and 8 weeks
measure: Number of Participants With Adverse Events During Double-blind Phase
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
Study officials:
affiliation: Novartis
name: Novartis Novartis
role: STUDY_CHAIR
References: