NCT00299806

Brief Summary

Assessing the safety and efficacy of SPP100 (Aliskiren) regimen in patients with severe hypertension

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_3 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

First Submitted

Initial submission to the registry

March 3, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2006

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

7 months

First QC Date

March 3, 2006

Last Update Submit

November 16, 2016

Conditions

Hypertension

Keywords

Hypertension, aliskiren, blood pressure, rennin

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events after 8 weeks

Secondary Outcomes (3)

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

  • Average sitting systolic blood pressure/mean sitting diastolic blood is < 160/100 mmHg or blood pressure reduction from baseline is > 20/10 mmHg after 8 weeks

  • Average sitting diastolic blood pressure < 90 mmHg or a reduction from baseline of > 10 mmHg 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:

  • Age: 20 - 80 years old
  • Gender: Male or female
  • Status: Outpatients
  • severe hypertension

You may not qualify if:

  • Patients with a clinically significant allergy
  • Patients who have received other investigational drug
  • Alcoholic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

Japan, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals, Japan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2006

First Posted

March 7, 2006

Study Start

April 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

JP(1)