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

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

SPP100 (aliskiren)

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Pharmacokinetics, pharmacodynamics, safety, RAS profile, SPP100, aliskiren, Japanese, essential hypertension, Mild to moderate essential hypertension

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Novartis Investigative Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

effect of aliskiren on the RAS profile

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

safety

Full Information

NCT ID

NCT00424541

First Posted

January 18, 2007

Last Updated

December 17, 2020

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00424541

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

SPP100 (aliskiren)

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

effect of aliskiren on the RAS profile

Title

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

Title

safety

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis

Organizational Affiliation

Investigative Site

Official's Role

Principal Investigator

Facility Information:

Facility Name

Novartis Investigative Site

City

Tokyo

ZIP/Postal Code

160-8618

Country

Japan

12. IPD Sharing Statement

Links:

URL

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

Description

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

Learn more about this trial

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

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