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Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Amlodipine Alone

Phase 3
Completed
Conditions
Hypertension
Registration Number
NCT00171002
Lead Sponsor
Novartis
Brief Summary

This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
936
Inclusion Criteria
  • Patients with uncomplicated, essential hypertension
Exclusion Criteria
  • Severe hypertension
  • 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 exclusion criteria may apply.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change from baseline in diastolic blood pressure after 8 weeks
Secondary Outcome Measures
NameTimeMethod
Change from baseline in systolic blood pressure after 8 weeks
Decrease in diastolic blood pressure of at least 10 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks
Diastolic blood pressure less than 90 mmHg after 8 weeks

Trial Locations

Locations (1)

Novartis Pharmaceuticals

🇨🇭

Basel, Switzerland

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