Amlodipine vs Nitrates Study 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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Amlodipine
- Drug: iso- 5 - mononitrate
- Procedure: Blood tests
- Procedure: Exercise Stress Test
Outcome Measures for this Clinical Trial
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
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Pfizer Industry
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00143195
