NCT00219180

Brief Summary

To evaluate the efficacy and safety of aliskiren alone and in combination with valsartan given to patients with essential hypertension

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,797

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Jun 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

June 1, 2005

Completed
3 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
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

September 12, 2005

Last Update Submit

May 15, 2017

Conditions

Hypertension

Keywords

Hypertension, Aliskiren

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in diastolic blood pressure after week 8

Secondary Outcomes (4)

  • Change from baseline in systolic blood pressure after week 8

  • Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 4 and 8 weeks

  • Blood pressure control target of < 140/90 mmHg after 4 and 8 weeks

  • Evaluate 24-hour ambulatory blood pressure monitoring in a subset of patients

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
  • 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 (2)

  • Wang GM, Li LJ, Fan L, Xu M, Tang WL, Wright JM. Renin inhibitors versus angiotensin receptor blockers for primary hypertension. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD012570. doi: 10.1002/14651858.CD012570.pub2.

    PMID: 40013543DERIVED

  • Oparil S, Yarows SA, Patel S, Fang H, Zhang J, Satlin A. Efficacy and safety of combined use of aliskiren and valsartan in patients with hypertension: a randomised, double-blind trial. Lancet. 2007 Jul 21;370(9583):221-229. doi: 10.1016/S0140-6736(07)61124-6.

    PMID: 17658393DERIVED

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

June 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

May 17, 2017

Record last verified: 2017-05

Locations

US(1)DE(1)