NCT00219050

Brief Summary

To compare the safety and efficacy of an aliskiren-based regimen to a lisinopril-based regimen in the treatment of severe hypertension

Trial Health

90
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_3 hypertension

Geographic Reach
4 countries

4 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

February 1, 2005

Completed
7 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
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

February 25, 2011

Status Verified

February 1, 2011

Enrollment Period

9 months

First QC Date

September 12, 2005

Last Update Submit

February 24, 2011

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Evaluate safety through adverse events and laboratory abnormalities after 8 weeks

Secondary Outcomes (4)

  • Change from baseline in diastolic blood pressure after 8 weeks

  • Change from baseline in systolic blood pressure after 8 weeks

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

  • Diastolic blood pressure is less than 90 mmHg or reduction of 10 mmHg or greater from baseline after 8 weeks

Interventions

aliskirenDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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 (4)

Investigative Site

Berlin, Germany

Location

Investigative Site

Budapest, Hungary

Location

Investigative Site

Madrid, Spain

Location

Novartis Pharmaceuticals

Basel, Switzerland

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

  • 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

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

February 1, 2005

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

February 25, 2011

Record last verified: 2011-02

Locations

DE(1)HU(1)CH(1)ES(1)