NCT00262236

Brief Summary

This is a study for people diagnosed with hypertension to compare the safety and effectiveness of aliskiren alone and in combination with atenolol. Each patient will be in the study for 12 weeks.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
693

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_3 hypertension

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

November 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

December 2, 2005

Last Update Submit

November 16, 2016

Conditions

Hypertension

Keywords

Hypertension, Aliskiren, Atenolol, Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in diastolic blood pressure after 12 weeks

Secondary Outcomes (3)

  • Change from baseline in systolic blood pressure after 12 weeks

  • Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 12 weeks

  • Blood pressure of < 140/90 mmHg after 12 weeks

Interventions

AliskirenDRUG

Eligibility Criteria

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

You may qualify if:

  • Outpatients 18 years of age and older.
  • Patients with essential hypertension.

You may not qualify if:

  • Severe hypertension, Current diagnosis of heart failure, History or evidence of a secondary form of hypertension, Participation in any investigational drug study within one month of planned participation,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Investigative Centers, Germany

Location

Novartis

Basel, Switzerland

Location

Related Publications (1)

  • Dietz R, Dechend R, Yu CM, Bheda M, Ford J, Prescott MF, Keefe DL. Effects of the direct renin inhibitor aliskiren and atenolol alone or in combination in patients with hypertension. J Renin Angiotensin Aldosterone Syst. 2008 Sep;9(3):163-75. doi: 10.1177/1470320308096411.

    PMID: 18957387RESULT

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceutical

    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

December 2, 2005

First Posted

December 6, 2005

Study Start

November 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

CH(1)DE(1)