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NCT00143195 Clinical Trial

Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina

Myocardial Ischemia Clinical Trial

— ANISSA  

Official title:
Open Label Study Comparing Amlodipine vs Long-acting Nitrates in Patients With Chronic Stable Angina.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00143195
Other study ID # A0531076
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2001
Est. completion date January 2005

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date January 2005
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Amlodipine

• iso- 5 - mononitrate

Procedure:
• Blood tests

• Exercise Stress Test

Locations
Country Name City State
Greece Pfizer Investigational Site Athens Attika
Greece Pfizer Investigational Site Athens
Greece Pfizer Investigational Site Athens
Greece Pfizer Investigational Site Holargos/Athens
Greece Pfizer Investigational Site Loannina
Greece Pfizer Investigational Site N. Ionia
Greece Pfizer Investigational Site Patra
Greece Pfizer Investigational Site Rio, Patra
Greece Pfizer Investigational Site Thessaloniki
Greece Pfizer Investigational Site Thessaloniki
Greece Pfizer Investigational Site Voula/Athens
Greece Pfizer Investigational Site Zakynthos

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the time to 1mm ST depression
Secondary 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
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