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OpenTrials
Completed

NCT Number: NCT00143195

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 ischemia

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Key information

Conditions

Myocardial Ischemia Cardiovascular Diseases Heart Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Athens, Attica, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amlodipine

Drug

iso- 5 - mononitrate

Drug

Blood tests

Procedure

Exercise Stress Test

Procedure

Primary outcomes

  1. Evaluate the time to 1mm ST depression

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

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

Acronym: ANISSA

Important dates

Study start
2001
Study completion
2005
First posted
Sep 2, 2005
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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