NCT00219193

Brief Summary

To evaluate the blood pressure lowering effect and safety of the triple combination aliskiren / valsartan / HCTZ (300/320/25 mg) in patients with essential hypertension not adequately responsive to HCTZ 25 mg

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 Oct 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

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

Study Start

First participant enrolled

October 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

September 12, 2005

Last Update Submit

February 3, 2017

Conditions

Hypertension

Keywords

Hypertension, aliskiren, blood pressure, valsartan, HCTZ

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcomes (3)

  • Change from baseline in systolic and diastolic blood pressure after 4 weeks and 8 weeks

  • Change from baseline in standing blood pressure after 4 weeks and 8 weeks

  • Achieve blood pressure control target of < 140/90 mmHg after 8 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 (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Unknown Facility

Investigative Centers, Germany

Location

Related Publications (1)

  • Geiger H, Barranco E, Gorostidi M, Taylor A, Zhang X, Xiang Z, Zhang J. Combination therapy with various combinations of aliskiren, valsartan, and hydrochlorothiazide in hypertensive patients not adequately responsive to hydrochlorothiazide alone. J Clin Hypertens (Greenwich). 2009 Jun;11(6):324-32. doi: 10.1111/j.1751-7176.2009.00114.x.

    PMID: 19527323RESULT

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

October 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

US(1)DE(1)