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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 pressure

Proportion 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

Page last updated: October 19, 2009

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