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Demonstrate Non-inferiority of Combination of 5 mg Amlodipine and 80 mg Valsartan to 160 mg Valsartan

Information source: Novartis
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Valsartan/ amlodipine (Drug); valsartan (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Novartis

Overall contact:
Novartis Pharmaceuticals, Phone: 41 61 324 1111

Summary

The purpose of the present study is to assess the non-inferiority of the efficacy and safety of fixed dose combination of 5 mg amlodipine and 80 mg valsartan compared to 160 mg valsartan 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, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: To compare the blood pressure lowering efficacy with baseline at week 12 by office blood pressure measurement between a single pill combination of 5mg amlodipine and 80 mg valsartan and 160 mg valsartan

Secondary outcome: To compare tolerability, safety, and other BP lowering efficacy comparison including ambulatory blood pressure measurement (ABPM) parameters at week 12 between a single pill combination of 5mg amlodipine and 80 mg valsartan and 160 mg valsartan.

Eligibility

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

Criteria:

Inclusion Criteria:

- Patients over 18 years of age and under the diagnosis of hypertension with 140 mmHg

<=sitting systolic blood pressure <= 180 mmHg or 90 mmHg <= sitting diastolic blood pressure <= 120 mmHg, or for high risk patients under the diagnosis of hypertension with 130 mmHg <= sitting systolic blood pressure <= 180 mmHg or 80 mmHg <= sitting diastolic blood pressure <= 120 mmHg will be recruited.

Exclusion Criteria:

- Patients with these conditions below will be excluded: women who are pregnant, intend

to become pregnant or breastfeeding, or patients who have severe medical condition(s) that in the view of the Investigator prohibits participation in the study, or patients 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

Novartis Pharmaceuticals, Phone: 41 61 324 1111

Taipei 11217, Taiwan; Recruiting
Phone: 886-2-28757602
Additional Information

Starting date: June 2009
Last updated: February 16, 2010

Page last updated: October 04, 2010

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