Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina
NCT00143195
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- Outpatients > =18 years of age with diagnosed clinically stable angina pectoris
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina | |||
Official Title ICMJE | Open Label Study Comparing Amlodipine vs Long-Acting Nitrates in Patients With Chronic Stable Angina. | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Myocardial Ischemia | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 200 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | January 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Greece | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00143195 | |||
Other Study ID Numbers ICMJE | A0531076 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | April 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |