NCT00424541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
Completed

Started Jan 2007

Typical duration for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 21, 2020

Status Verified

November 1, 2007

First QC Date

January 18, 2007

Last Update Submit

December 17, 2020

Conditions

Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • effect of aliskiren on the RAS profile

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

  • safety

Interventions

SPP100 (aliskiren)DRUG

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • days before treatment: ≥ 90 mmHg and \< 110 mmHg
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Tokyo, 160-8618, Japan

Location

Related Links

MeSH Terms

Conditions

HypertensionEssential Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Novartis

    Investigative Site

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 18, 2007

First Posted

January 19, 2007

Study Start

January 1, 2007

Study Completion

August 1, 2007

Last Updated

December 21, 2020

Record last verified: 2007-11

Locations

JP(1)