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NCT00392262 Clinical Trial

A Study to Evaluate the Combination of Valsartan + Amlodipine in Hypertensive Patients

Hypertension Clinical Trial

Official title:
An Multicenter Study to Evaluate the Efficacy and Tolerability of a 4-week Therapy With the Combination of Valsartan 160mg + Amlodipine 5mg in Hypertensive Patients Not Adequately Responding to 4-week Treatment With Amlo 5mg or Felodipine 5mg in Monotherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00392262
Other study ID # CVAA489ADE03
Secondary ID
Status Completed
Phase Phase 3
First received October 23, 2006
Last updated November 16, 2016
Start date August 2006
Est. completion date February 2007

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with amlodipine or felodipine alone.

Recruitment information / eligibility
Status Completed
Enrollment 224
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Male or female patients (18 years)

2. Patients with moderate essential hypertension (untreated must have MSSBP =160 and <180 mmHg at Visit 1, treated must have MSSBP <180 mmHg at Visit 1) (WHO grade II)

Exclusion Criteria:

1. Severe hypertension(MSDBP =110 mmHg or MSSBP = 180 mmHg)

2. Pregnant or nursing women

3. Treated hypertensive patients with controlled hypertension under current therapy (diastolic BP < 90 mmHg and systolic BP < 140 mmHg)

4. A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• valsartan + amlodipine

Locations
Country Name City State
Switzerland Novartis Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

Brachmann J, Ansari A, Mahla G, Handrock R, Klebs S. Effective and safe reduction of blood pressure with the combination of amlodipine 5 mg and valsartan 160 mg in hypertensive patients not controlled by calcium channel blocker monotherapy. Adv Ther. 2008 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To investigate whether 4 weeks treatment with valsartan 160mg + amlo 5mg provide an add'l mean sitting systolic blood pressure reduction in patients not adequately responding to 4 weeks treatment with amlo 5mg or felodipine 5mg
Secondary Mean sitting diastolic blood pressure (analogously & explorative)
Secondary Normalization (analogously & explorative)
Secondary Responder rate. (analogously & explorative)
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