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

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension; High Blood Pressure

Treatments: Drug: Amlodipine 5mg/Valsartan 80 mg; Drug: Valsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01070043

CVAA489ATW01

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Amlodipine 5mg/Valsartan 80 mg

Experimental group

Description:

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.

Treatment:

Drug: Amlodipine 5mg/Valsartan 80 mg

Valsartan 160 mg

Active Comparator group

Description:

In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.

Treatment:

Drug: Valsartan

Run-In Valsartan 80 mg

Other group

Description:

During run-in period, oral valsartan 80 mg once daily for 4 weeks.

Treatment:

Drug: Valsartan