Official Title: “Open Label Study Comparing Amlodipine vs Long-Acting Nitrates in Patients With Chronic Stable Angina.”

The objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and symptomatic myocardial ischemia

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Amlodipine
• Drug: iso- 5 - mononitrate
• Procedure: Blood tests
• Procedure: Exercise Stress Test

Primary Measures

• Evaluate the time to 1mm ST depression

Secondary Measures

• The number of patients experiencing angina attacks The frequency of hospitalizations due to angina attacks Time to onset of 1mm ST segment depression Total external workload performed Safety

Inclusion Criteria:

• Outpatients > =18 years of age with diagnosed clinically stable angina pectoris

Exclusion Criteria:

• Patients with congestive heart failure, clinically significant cardiovascular disease, standing systolic blood pressure of less than 100mmHg, concomitant anti-anginal therapies similar to sublingual NTG

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00143195

Study ID Number: A0531076

ClinicalTrials.gov Identifier: NCT00143195

Health Authority: Greece: National Organization of Medicines

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting: