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Clinical Trials/NCT00262236
NCT00262236
Completed
Phase 3

A Twelve-week, Randomized, Double-blind, Parallel-group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Atenolol in Patients With Essential Hypertension

Novartis1 site in 1 country693 target enrollmentNovember 2005
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ConditionsHypertension
DrugsAliskiren

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Hypertension
Sponsor
Novartis
Enrollment
693
Locations
1
Primary Endpoint
Change from baseline in diastolic blood pressure after 12 weeks
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2005
End Date
August 2006
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Novartis
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • •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,
  • •Other protocol-defined inclusion/exclusion criteria may apply

Outcomes

Primary Outcomes

Change from baseline in diastolic blood pressure after 12 weeks

Secondary Outcomes

  • Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 12 weeks
  • Blood pressure of < 140/90 mmHg after 12 weeks
  • Change from baseline in systolic blood pressure after 12 weeks

Study Sites (1)

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