NCT00294710

Brief Summary

This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension

Trial Health

90
On Track

Trial Health Score

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

Enrollment
976

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Mar 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

March 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

1.3 years

First QC Date

February 18, 2006

Last Update Submit

November 7, 2011

Conditions

Hypertension

Keywords

Hypertension, aliskiren, hydrochlorothiazide, amlodipine

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in diastolic blood pressure after 52 weeks

Secondary Outcomes (3)

  • Change from baseline in systolic and diastolic blood pressure after 52 weeks

  • Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks

  • Achieve blood pressure control target of < 140/90 mmHg after 12 weeks

Interventions

AliskirenDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with essential hypertension

You may not qualify if:

  • Severe hypertension
  • History or evidence of a secondary form of hypertension
  • History of myocardial infarction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis

East Hanover, New Jersey, 07936, United States

Location

Unknown Facility

Investigative Centers, Germany

Location

Related Publications (1)

  • Schmieder RE, Philipp T, Guerediaga J, Gorostidi M, Smith B, Weissbach N, Maboudian M, Botha J, van Ingen H. Long-term antihypertensive efficacy and safety of the oral direct renin inhibitor aliskiren: a 12-month randomized, double-blind comparator trial with hydrochlorothiazide. Circulation. 2009 Jan 27;119(3):417-25. doi: 10.1161/CIRCULATIONAHA.107.750745. Epub 2009 Jan 12.

    PMID: 19139391DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    PRINCIPAL INVESTIGATOR

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

February 18, 2006

First Posted

February 22, 2006

Study Start

March 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

DE(1)US(1)