Status:
COMPLETED
Pharmacokinetic and Pharmacodynamic Profiles of Aliskiren in Japanese Patients With Mild to Moderate Essential Hypertension
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
Brief Summary
This study will evaluate the pharmacokinetic profile, the effect of rennin inhibition and the relationship among pharmacokinetics, renin-angiotensin system (RAS) biomarkers, and blood pressure lowerin...
Eligibility Criteria
Inclusion
- Japanese patients with mild to moderate essential hypertension aged 20 to 80 years
- Blood pressure: Mean (based on 3 recordings at 1-2 minute intervals) sitting diastolic blood pressure values on 14 days or 3 days before the treatment should meet the following criteria:
- 14 days before treatment: ≥ 90 mmHg and \< 110 mmHg
- 3 days before treatment: ≥ 95 mmHg and \< 110 mmHg
- The difference in mean sitting diastolic blood pressure between 14 days and 3 days before the treatment is within 10 mmHg
- Body weight no less than 50 kg
Exclusion
- Patients with mean (based on 3 recordings at 1-2 minute intervals) systolic blood pressure ≥ 180 mmHg and/or mean diastolic blood pressure ≥ 110 mmHg at Day -28, Day -14 and Day -3.
- Patients with or suspected of having secondary hypertension
- Patients suspected of having malignant hypertension
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00424541
Start Date
January 1 2007
End Date
August 1 2007
Last Update
December 21 2020
Active Locations (1)
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1
Novartis Investigative Site
Tokyo, Japan, 160-8618