NCT00219128

Brief Summary

Evaluate the blood pressure lowering effect of aliskiren 150mg, 300mg and 600mg compared to placebo in patients with essential hypertension

Trial Health

87
On Track

Trial Health Score

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

Enrollment
671

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Nov 2004

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

Study Start

First participant enrolled

November 1, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

November 8, 2011

Status Verified

June 1, 2006

Enrollment Period

7 months

First QC Date

September 12, 2005

Last Update Submit

November 7, 2011

Conditions

Hypertension

Keywords

Hypertension, aliskiren, blood pressure, placebo

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcomes (5)

  • Change from baseline in systolic blood pressure after 8 weeks

  • Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 4 weeks and 8 weeks

  • Blood pressure <140/90 mmHg after 4 weeks and 8 weeks

  • Evaluate potential return of hypertension at 4 days and 2 weeks after 8 weeks

  • Evaluate high and low level drug effect using 24 hour blood pressure monitoring

Interventions

aliskirenDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with essential hypertension
  • Patients who are eligible and able to participate in the study

You may not qualify if:

  • Severe hypertension
  • History or evidence of a secondary form of hypertension
  • History of Hypertensive encephalopathy or cerebrovascular accident.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

November 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

November 8, 2011

Record last verified: 2006-06

Locations

US(1)