NCT00219167

Brief Summary

After a wash-out (1 to 2 weeks), and 2 to 4 week single-blind placebo run-in period, eligible patients will be randomized to receive lisinopril 10 mg, aliskiren 75 mg, 150 mg or 300 mg for a period of 8 weeks

Trial Health

87
On Track

Trial Health Score

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

Enrollment
355

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_3 hypertension

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

April 1, 2005

Completed
5 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
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

September 12, 2005

Last Update Submit

November 16, 2016

Conditions

Hypertension

Keywords

hypertensionaliskirenage

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in average 24 hour systolic ambulatory blood pressure after 8 weeks

Secondary Outcomes (5)

  • Change from baseline in average 24 hour diastolic ambulatory blood pressure after 8 weeks

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

  • Change from baseline in daytime diastolic ambulatory blood pressure after 8 weeks

  • Change from baseline in daytime systolic ambulatory blood pressure after 8 weeks

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

Interventions

aliskirenDRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients with at least 65 years-old

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)

Novartis Pharmaceuticals

Basel, Switzerland

Location

Related Publications (2)

  • Verdecchia P, Calvo C, Mockel V, Keeling L, Satlin A. Safety and efficacy of the oral direct renin inhibitor aliskiren in elderly patients with hypertension. Blood Press. 2007;16(6):381-91. doi: 10.1080/08037050701717014.

    PMID: 18058456RESULT

  • Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.

    PMID: 33089502DERIVED

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

April 1, 2005

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

CH(1)