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Clinical Trials/NCT00171535
NCT00171535CompletedPhase 3

A Study to Evaluate the Safety and Efficacy of Valsartan/Amlodipine Compared to Lisinopril/Hydrochlorothiazide Given Once Daily for 6 Weeks is Patients With Severe Hypertension

Novartis2 sites in 1 country130 target enrollmentStarted: October 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Novartis
Enrollment
130
Locations
2
Primary Endpoint
Adverse events and serious adverse events at each study visit for 6 weeks
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study will assess the effectiveness and safety of different combination antihypertensive treatments in patients with severe hypertension

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with severe hypertension

Exclusion Criteria

  • •History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
  • •Liver, kidney, or pancreas disease
  • •Insulin dependent diabetes
  • •Allergy to certain medications used to treat high blood pressure
  • •Other protocol-defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

Adverse events and serious adverse events at each study visit for 6 weeks

Secondary Outcomes

  • Sitting and standing blood pressure measurements after 6 weeks
  • Laboratory test data after 6 weeks
  • Vital signs at each study visit for 6 weeks

Investigators

Sponsor
Novartis
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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