NCT00219037

Brief Summary

Assess the long-term safety and tolerability of aliskiren, with the optional addition of HCTZ, in patients with essential hypertension, to ensure long term blood pressure control and protect against end organ damage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,955

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Jun 2004

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

June 1, 2004

Completed
1.3 years 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
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

November 8, 2011

Status Verified

June 1, 2006

Enrollment Period

1.3 years

First QC Date

September 12, 2005

Last Update Submit

November 7, 2011

Conditions

Hypertension

Keywords

Hypertension, blood pressure, aliskiren

Outcome Measures

Primary Outcomes (1)

  • Adverse events, laboratory abnormalities, serious adverse events

Secondary Outcomes (5)

  • Change from baseline in mean sitting diastolic blood pressure after 12 months

  • Change from baseline in mean sitting systolic blood pressure after 12 months

  • Change from baseline in standing systolic blood and diastolic pressure after 12 months

  • Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline

  • Blood pressure less than 140/90 mmHg

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)

Unknown Facility

Investigative Sites, Germany

Location

Related Publications (1)

  • Sica D, Gradman AH, Lederballe O, Kolloch RE, Zhang J, Keefe DL. Long-term safety and tolerability of the oral direct renin inhibitor aliskiren with optional add-on hydrochlorothiazide in patients with hypertension: a randomized, open-label, parallel-group, multicentre, dose-escalation study with an extension phase. Clin Drug Investig. 2011 Dec 1;31(12):825-37. doi: 10.1007/BF03256921.

    PMID: 22035463DERIVED

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
SINGLE
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

June 1, 2004

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

November 8, 2011

Record last verified: 2006-06

Locations

DE(1)