NCT00260923

Brief Summary

This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in the study for 8 weeks

Trial Health

90
On Track

Trial Health Score

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

Enrollment
641

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Nov 2005

Geographic Reach
2 countries

2 active sites

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, 2005

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2005

Completed
11 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 8, 2011

Status Verified

November 1, 2011

Enrollment Period

1 year

First QC Date

November 30, 2005

Last Update Submit

November 7, 2011

Conditions

Hypertension

Keywords

hypertensionaliskirenblood pressure

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcomes (2)

  • Change from baseline in systolic blood pressure after 8 weeks

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

Interventions

aliskirenDRUG

Eligibility Criteria

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

You may qualify if:

  • Male and female outpatients 18 years of age and older
  • 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 (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Unknown Facility

Investigative Centers, Germany

Location

Related Publications (1)

  • Puig JG, Schunkert H, Taylor AA, Boye S, Jin J, Keefe DL. Evaluation of the dose--response relationship of aliskiren, a direct renin inhibitor, in an 8-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled study in adult patients with stage 1 or 2 essential hypertension. Clin Ther. 2009 Dec;31(12):2839-50. doi: 10.1016/j.clinthera.2009.12.006.

    PMID: 20110023DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Sponsor GmbH

    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

November 30, 2005

First Posted

December 2, 2005

Study Start

November 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

US(1)DE(1)