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

NCT ID: NCT00424541

Last Updated: 2020-12-21

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.

Detailed Description

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Conditions

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Hypertension

Keywords

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Pharmacokinetics, pharmacodynamics, safety, RAS profile, SPP100, aliskiren, Japanese, essential hypertension Mild to moderate essential 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

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigative Site

Locations

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Novartis Investigative Site

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2500

Results for CSPP100A1104 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CSPP100A1104

Identifier Type: -

Identifier Source: org_study_id