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

Novartis

Status and phase

Completed

Phase 1

Conditions

Hypertension

Treatments

Drug: SPP100 (aliskiren)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00424541

CSPP100A1104

Details and patient eligibility

About

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.

Enrollment

34 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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