Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stage 2 Systolic Hypertension
Intervention: valsartan, amlodipine, HCTZ (Drug); Losartan, HCTZ followed by valsartan, amlodipine, HCTZ (Drug)
Phase: Phase 4
Sponsored by: Novartis
Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: 862-778-8300
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).
Official title: A 12-week Multicenter, Randomized, Double-blind, Parallel-group, Active-control Study to Evaluate the Antihypertensive Efficacy and Safety of Valsartan/Amlodipine-based Regimen Versus a Losartan-based Regimen in Patients With Stage 2 Systolic Hypertension
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in Mean Sitting Systolic Blood Pressure After 6 Weeks
Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks
Cumulative Percentage of Patients Achieving Blood Pressure Control
Cumulative Percentage of Treatment Responders
Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks
Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit
Minimum age: 18 Years.
Maximum age: N/A.
- Male or female outpatient of 18 years of age or greater
- Stage 2 systolic hypertension defined as office Mean Sitting Systolic blood pressure
(MSSBP) greater than or equal to 160 and < 200 mmHg at randomization
- Patients who were able to participate in the study, and who gave written informed
consent before any study assessment was performed.
- Office systolic blood pressure >200 and/or mean sitting diastolic blood pressure
(MSDBP) greater than or equal to 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
Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
sites in USA, East Hanover, New Jersey, United States
Starting date: July 2009
Last updated: March 1, 2011