NCT00219063

Brief Summary

To compare the aliskiren regimen versus the ramipril regimen on reduction in Blood Pressure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
844

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Feb 2005

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

February 1, 2005

Completed
7 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
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1.1 years

First QC Date

September 12, 2005

Last Update Submit

May 15, 2017

Conditions

Hypertension

Keywords

Hypertension, aliskiren, blood pressure, Ramipril, hydrochlorothiazide

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in diastolic blood pressure after 26 weeks

Secondary Outcomes (4)

  • Change from baseline in systolic blood pressure after 26 weeks

  • Change from baseline in diastolic blood pressure after 6 weeks and 12 weeks

  • Change from baseline in systolic blood pressure after 6 weeks and 12 weeks

  • Blood pressure control target of < 140/90 mmHg after 6, 12, and 26 weeks

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Location

Related Publications (1)

  • Andersen K, Weinberger MH, Egan B, Constance CM, Ali MA, Jin J, Keefe DL. Comparative efficacy and safety of aliskiren, an oral direct renin inhibitor, and ramipril in hypertension: a 6-month, randomized, double-blind trial. J Hypertens. 2008 Mar;26(3):589-99. doi: 10.1097/HJH.0b013e3282f3ad9a.

    PMID: 18300872RESULT

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

February 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

May 17, 2017

Record last verified: 2017-05

Locations

US(1)