Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina

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NCT00143195

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Study Location
Pfizer Investigational Site
Athens, Attika, 11527, Greece
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Myocardial Ischemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Outpatients > =18 years of age with diagnosed clinically stable angina pectoris

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Pfizer Clinical Trials Contact Center

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ALL GENDERS
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MULTIPLE SITES
Myocardial IschemiaAmlodipine vs Nitrates Study in Patients With Chronic Stable Angina
NCT00143195
  1. Athens, Attika
  2. Athens,
  3. Athens,
  4. Holargos/Athens,
  5. Loannina,
  6. N. Ionia,
  7. Patra,
  8. Rio, Patra,
  9. Thessaloniki,
  10. Thessaloniki,
  11. Voula/Athens,
  12. Zakynthos,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Drug: Amlodipine
  • Drug: iso- 5 - mononitrate
  • Procedure: Blood tests
  • Procedure: Exercise Stress Test
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
 (submitted: August 31, 2005)		200
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP