Status:
COMPLETED
Effect of Light Meal on Pharmacokinetic and Pharmacodynamics of Aliskiren in Patients With Mild to Moderate Hypertension
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the effect of a light meal on the pharmacokinetics and pharmacodynamics of aliskiren in patients with mild to moderate hypertension.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female outpatients, 18 to 65 years of age with mild to moderate hypertension
- Patients who are eligible and able to participate in the study
- Exclusion criteria:
- Severe hypertension
- Secondary form of hypertension.
- Type 1 or type 2 diabetes mellitus
- Serum potassium out side laboratory reference range
- Any history of hypertensive encephalopathy or cerebrovascular accident
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00933920
Start Date
June 1 2009
Last Update
December 21 2020
Active Locations (5)
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1
Novartis Investigator Site
Coimbatore, India
2
Novartis Investigative Site
Hyderabaad, India
3
Novartis Investigator Site
Hyderabaad, India
4
Novartis Investigator Site
Mangalore, India