The Effects of Moderate and Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy
Information source: Novartis
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: valsartan and amlodipine (Drug); valsartan and amlodipine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Novartis Overall contact:
Novartis Pharmaceuticals, Phone: 1-862-778-8300
Summary
The purpose of this trial is to compare blood pressure lowering efficacy of moderate
Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 /
10 mg) in patients uncontrolled on ARB monotherapy, other than Valsartan
Clinical Details
Official title: A Multicenter, Randomized, Double Blind, Parallel Design Trial to Evaluate the Blood Pressure Lowering Efficacy Comparing Moderate Versus Aggressive Treatment Regimen of Valsartan + Amlodipine in Patients Uncontrolled on ARB Monotherapy
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in Mean Sitting Systolic Blood Pressure (herein, MSSBP) after 4 weeks
Secondary outcome: Proportion of patients achieving blood pressure goal (<140/90 mmHg), at 2, 4, 8 and 12 weeks
Eligibility
Minimum age: 18 Months.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 Years of age or older
- Mean Sitting Systolic Blood Pressure (the top number) of or higher than 150 mmHg and
lower than 200 mmHg while on Angiotensin-Receptor Blocker monotherapy for a minimum
period of 28 days prior to randomization
Exclusion Criteria:
- Mean Sitting Systolic Blood Pressure (the top number) of or higher than 200 mmHg
and/or Mean Sitting Diastolic Blood Pressure of or higher than 120 mmHg
- Transient ischemic attack (mini-stroke), myocardial infarction (heart attack), all
types of revascularization procedures in the last 6 months
Locations and Contacts
Novartis Pharmaceuticals, Phone: 1-862-778-8300
Egan Healthcare, Metairie, Louisiana 70002, United States; Recruiting
study staff, Phone: 504-220-6275
Additional Information
Starting date: March 2008
Ending date: January 2009
Last updated: May 27, 2008
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