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NCT00170963 Clinical Trial

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

Hypertension Clinical Trial

Official title:
Valsartan/Amlodipine 160/5 mg or 160/10 mg Versus Valsartan 160 mg Alone for 8 Weeks in Hypertensive Patients Who Are Not Adequately Controlled on Valsartan 160 mg Monotherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00170963
Other study ID # CVAA489A2305
Secondary ID
Status Completed
Phase Phase 3
First received September 10, 2005
Last updated May 15, 2017
Start date October 2004
Est. completion date June 2005

Study information
Verified date May 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 1018
Est. completion date June 2005
Est. primary completion date June 2005
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• valsartan/amlodipine

Locations
Country Name City State
Switzerland Novartis Pharmaceuticals Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in diastolic blood pressure after 8 weeks
Secondary Change from baseline in mean systolic blood pressure after 8 weeks
Secondary Decrease in diastolic blood pressure of at least 10 mmHg or diastolic blood pressure was less than 90 mmHg after 8 weeks
Secondary Diastolic blood pressure less than 90 mmHg after 8 weeks
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