To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone

Phase 4

Completed

• Conditions: Hypertension; High Blood Pressure
• Interventions: Drug: Amlodipine 5mg/Valsartan 80 mg; Drug: Valsartan

• Registration Number: NCT01070043
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-02-06
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-09
• Results First Submitted: 2011-09-13
• Results First Submitted QC: 2011-09-13
• Last Update Submitted: 2011-09-13
• Results First Posted: 2011-10-19
• Last Update Posted: 2011-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amlodipine 5mg/Valsartan 80 mg	Amlodipine 5mg/Valsartan 80 mg	During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
Run-In Valsartan 80 mg	Valsartan	During run-in period, oral valsartan 80 mg once daily for 4 weeks.
Valsartan 160 mg	Valsartan	In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement	Baseline and 8 weeks	Two arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in mean sitting diastolic blood pressure (msDBP) was calculated comparing the Week 8 readings to the readings taken at Baseline.
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement	Baseline and 8 weeks	Two arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in mean sitting systolic blood pressure (msSBP) was calculated comparing the Week 8 readings to the readings taken at baseline.

Secondary Outcome Measures

Name	Time	Method
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	Baseline and 8 weeks	Validated automated ambulatory blood pressure monitors were dispensed to participants with instructions on correct use. Automated blood pressure readings were obtained every 15-30 minutes during waking hours and every 30-60 minutes during sleep for a total of 24 hours. The change in mean diastolic blood pressure (mDBP) over 24 hours was measured from baseline to 8 weeks of treatment during the double-blind.
Number of Participants With Adverse Events During Double-blind Phase	8 weeks
Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours	Baseline and 8 weeks	Validated automated ambulatory blood pressure monitors were dispensed to participants with instructions on correct use. Automated blood pressure readings were obtained every 15-30 minutes during waking hours and every 30-60 minutes during sleep for a total of 24 hours. The change in mean systolic blood pressure (mSBP) over 24 hours was measured from baseline to 8 weeks of treatment during the double-blind phase.