EXforge As Compared to Losartan Treatment in Stage 2 Systolic Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stage 2 Systolic Hypertension
Intervention: losartan, HCT, followed by valsartan, amlodipine, HCT (Drug); valsartan, amlodipine, HCT (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: 862-778-8300
Overall contact:
Novartis Pharmaceuticals, Phone: 862-778-8300
Summary
This study will compare the antihypertensive efficacy and safety of a
valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage
2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160
and less than 200 mmHg.
Clinical Details
Official title: A 12-week Multicenter, Randomized, Double-blind, Parallel-group, Active-control Study to Evaluate the Antihypertensive Efficacy and Safety of an Exforge® (Valsartan/Amlodipine)-Based Regimen Versus a Losartan-based Regimen in Patients With Stage 2 Systolic Hypertension
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Primary outcome: Change in mean sitting systolic blood pressure
Secondary outcome: Change in mean sitting diastolic blood pressureProportion of patients achieving blood pressure control (defined as patients achieving mean sitting blood pressure less than 140 systolic and less than 90 diastolic Proportion of treatment responders Assessment of which treatment regimen achieves blood pressure control faster (blood pressure control Difference in change in mean sitting systolic and diastolic blood pressure
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Stage 2 systolic hypertension defined as office Mean Sitting Systolic blood pressure
(BP) greater than 160 and less than 200 mmHg
Exclusion Criteria:
- Office systolic blood pressure >200 and/or diastolic blood pressure >110 mmHg at
Visit 1.
- Use of four (4) or more antihypertensive medications within 30 days of Visit 1.
- Refractory hypertension, defined as blood pressure >140/90 mmHg while taking three
(3) drugs at the maximum dose of each drug, one of which must be a diuretic. (Therapy
with a fixed-dose combination of two active medications represents two drugs).
- Inability to safely discontinue all antihypertensive medications for 1-2 weeks prior
to randomization.
Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Novartis Pharmaceuticals, Phone: 862-778-8300
Health Trends Research, LLC, Baltimore, Maryland, United States; Recruiting
Novartis Pharmaceuticals, Phone: 862-778-8300
Additional Information
Starting date: July 2009
Last updated: September 14, 2009
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