NCT00311012

Brief Summary

This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with essential hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
445

participants targeted

Target at P75+ for phase_2 hypertension

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_2 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

August 1, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
Last Updated

November 8, 2011

Status Verified

June 1, 2006

Enrollment Period

7 months

First QC Date

March 31, 2006

Last Update Submit

November 7, 2011

Conditions

Hypertension

Keywords

Hypertension, Aliskiren

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in mean sitting diastolic blood pressure after 8 weeks

Secondary Outcomes (3)

  • Change from baseline in mean sitting systolic blood pressure after 8 weeks

  • Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline after 8 weeks

  • Evaluate response to various doses by assessing the difference in mean sitting diastolic blood pressure after 8 weeks

Interventions

AliskirenDRUG

Eligibility Criteria

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

You may qualify if:

  • Mild to moderate essential hypertension
  • Age: ≥20 years old and \<80 years old (at time informed consent obtained)
  • Sex: N/A
  • Admission status: Outpatient

You may not qualify if:

  • Pregnant women, lactating women, potentially pregnant women, or women who wish to become pregnant
  • Patients having a mean sitting diastolic blood pressure of ≥110 mmHg and/or a mean sitting systolic blood pressure of ≥180 mmHg at either Visit 2 or 3
  • Patients with secondary hypertension as a complication or patients suspected of having secondary hypertension(due to aortic coarctation, primary aldosteronism, coarctation of renal artery, renal hypertension
  • Patients suspected of having malignant hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

Tokyo, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals, Japan

    Novartis Pharmaceuticals, Japan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 31, 2006

First Posted

April 5, 2006

Study Start

August 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

November 8, 2011

Record last verified: 2006-06

Locations

JP(1)