Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myocardial Ischemia
Intervention: Amlodipine (Drug); iso- 5 - mononitrate (Drug); Blood tests (Procedure); Exercise Stress Test (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
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
Clinical Details
Official title: Open Label Study Comparing Amlodipine vs Long-Acting Nitrates in Patients With Chronic Stable Angina.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Evaluate the time to 1mm ST depression
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Pfizer Investigational Site, Athens 123 51, Greece
Pfizer Investigational Site, ATHENS, Greece
Pfizer Investigational Site, Patra 26335, Greece
Pfizer Investigational Site, Thessaloniki 54639, Greece
Pfizer Investigational Site, loannina 45500, Greece
Pfizer Investigational Site, Voula/Athens, Greece
Pfizer Investigational Site, Holargos/Athens 11525, Greece
Pfizer Investigational Site, Thessaloniki 546 36, Greece
Pfizer Investigational Site, N. Ionia 143 88, Greece
Pfizer Investigational Site, Rio, Patra 26499, Greece
Pfizer Investigational Site, Zakynthos 29100, Greece
Pfizer Investigational Site, Athens, Attika 11527, Greece
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org Posting:
Starting date: April 2001
Ending date: January 2005
Last updated: April 17, 2007
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