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

NCT ID: NCT01070043

Last Updated: 2011-10-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-09-30

Brief Summary

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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

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Conditions

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Hypertension High Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Amlodipine 5mg/Valsartan 80 mg

Intervention Type DRUG

Combination therapy of Amlodipine/Valsartan 5mg/80mg one dosage daily with one single tablet size for 8 weeks.

Valsartan 160 mg

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

Group Type ACTIVE_COMPARATOR

Valsartan

Intervention Type DRUG

For run-in period, Valsartan 80 mg daily in one dosage with one single tablet size for 4 weeks.

Monotherapy for double blind treatment period in one dosage (Valsartan 160mg) daily with one single tablet size for 8 weeks

Run-In Valsartan 80 mg

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

Group Type OTHER

Valsartan

Intervention Type DRUG

For run-in period, Valsartan 80 mg daily in one dosage with one single tablet size for 4 weeks.

Monotherapy for double blind treatment period in one dosage (Valsartan 160mg) daily with one single tablet size for 8 weeks

Interventions

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Amlodipine 5mg/Valsartan 80 mg

Combination therapy of Amlodipine/Valsartan 5mg/80mg one dosage daily with one single tablet size for 8 weeks.

Intervention Type DRUG

Valsartan

For run-in period, Valsartan 80 mg daily in one dosage with one single tablet size for 4 weeks.

Monotherapy for double blind treatment period in one dosage (Valsartan 160mg) daily with one single tablet size for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Exforge Diovan

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Novartis

Role: STUDY_CHAIR

Novartis

Locations

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Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CVAA489ATW01

Identifier Type: -

Identifier Source: org_study_id