Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina

Phase 4

Completed

• Conditions: Myocardial Ischemia

• Registration Number: NCT00143195
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-04
• Study Completion: 2005-01
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-02
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluate the time to 1mm ST depression

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇷 Zakynthos, Greece