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

Condition(s) targeted: Hypertension

Intervention: SPP100 (aliskiren) (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Principal Investigator, Affiliation: Investigative Site

Overall contact:
Novartis Tokyo, Phone: +81 3 3797 8748

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.

Official title: A Multiple Center, Randomized, Double Blind, Parallel Group, Multiple Oral Doses Study to Evaluate the Pharmacokinetic and Pharmacodynamic Profiles of 150 mg and 300 mg of SPP100 in Japanese Patients With Mild to Moderate Essential Hypertension

Study design: Interventional, Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study

Primary outcome: pharmacokinetic profile of aliskiren administration after meal Day 1, Day 14, and Day 28

Secondary outcome:

effect of aliskiren on the RAS profile

relationship among steady state pharmacokinetics, change in RAS biomarkers and blood pressure lowering effect of aliskiren

safety

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

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

Novartis Tokyo, Phone: +81 3 3797 8748

Novartis Investigative Site, Tokyo 160-8618, Japan; Recruiting
Novartis Tokyo, Phone: +81 3 3797 8748

Starting date: January 2007
Last updated: June 21, 2007