A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Diabetes
Intervention: aliskiren (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
Summary
To evaluate the blood pressure lowering effect and safety of aliskiren used in combination
with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not
adequately responsive to the combination of valsartan and hydrochlorothiazide
Clinical Details
Official title: A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study Evaluating the Efficacy & Safety of Aliskiren in Patients With Diabetes & Hypertension Not Adequately Responsive to the Combination of Valsartan 160 mg & Hydrochlorothiazide 25 mg
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in diastolic blood pressure after 12 weeks
Secondary outcome: Change from baseline in systolic blood pressure after 12 weeksChange from baseline in systolic and diastolic blood pressure after 6 weeks Diastolic blood pressure of < 80 mmHg or a reduction from baseline of diastolic blood pressure of > 10 mmHg after 12 weeks Achieve mean sitting blood pressure control target of < 130/80 mmHg after 12 weeks
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
- Patients with essential hypertension
- Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus.
- Patients who are eligible and able to participate in the study
Exclusion Criteria
- Severe hypertension
- Uncontrolled diabetes type I and II
- History or evidence of a secondary form of hypertension
- History of Hypertensive encephalopathy or cerebrovascular accident.
Other protocol-defined exclusion criteria may apply.
Locations and Contacts
Novartis Pharmaceuticals, Basel, Switzerland
Additional Information
Starting date: June 2005
Last updated: January 9, 2008
|
