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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00424541

Enrollment

Registered

2007-01-19

Start date

2007-01-31

Completion date

2007-08-31

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

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

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.

Interventions

DRUGSPP100 (aliskiren)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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/

Design outcomes

Primary

Measure	Time frame
pharmacokinetic profile of aliskiren administration after meal Day 1, Day 14, and Day 28	—

Secondary

Measure	Time frame
effect of aliskiren on the RAS profile	—
relationship among steady state pharmacokinetics, change in RAS biomarkers and blood pressure lowering effect of aliskiren	—
safety	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026