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
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