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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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SPP100 (aliskiren)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No