NCT00219115

Brief Summary

To evaluate the blood pressure lowering effects of the combination of aliskiren 300 mg and HCTZ 25 mg in obese patients with essential hypertension inadequately treated with HCTZ 25 mg, compared to irbesartan or amlodipine with HCTZ or HCTZ alone.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
493

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Jan 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

January 1, 2005

Completed
8 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

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

September 12, 2005

Last Update Submit

February 3, 2017

Conditions

Hypertension

Keywords

Hypertension, aliskiren, blood pressure, irbesartan, amlodipine, hydrochlorothiazide

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in mean sitting diastolic blood pressure after 8 weeks

Secondary Outcomes (4)

  • Change from baseline in mean sitting systolic blood pressure after 8 weeks

  • Evaluate number mean sitting systolic/diastolic response from baseline to weeks 4 and 8

  • Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after week 8

  • Achieve mean sitting blood pressure control target of < 140/90 mmHg after week 8

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 with body mass index ≥ 30 kg/m2

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)

  • Jordan J, Engeli S, Boye SW, Le Breton S, Keefe DL. Direct Renin inhibition with aliskiren in obese patients with arterial hypertension. Hypertension. 2007 May;49(5):1047-55. doi: 10.1161/HYPERTENSIONAHA.106.084301. Epub 2007 Mar 12.

    PMID: 17353513RESULT

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

January 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

US(1)DE(1)