Pharmacokinetic and Pharmacodynamic Profiles of Aliskiren in Japanese Patients With Mild to Moderate Essential Hypertension

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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 lowering effects of oral doses of SPP100 in Japanese patients with mild to moderate essential hypertension. Safety will also be evaluated.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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