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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

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Novartis, Study Chair, Affiliation: Novartis

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.

Clinical Details

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

Primary outcome:

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

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Taipei 11217, Taiwan
Additional Information

Starting date: June 2009
Last updated: September 13, 2011

Page last updated: August 23, 2015

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