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NCT02236741 Clinical Trial

The Use of Pramipexole and Other Dopamine Agonists and the Risks of Heart Failure and Pneumonia

Heart Failure Clinical Trial

Official title:
The Use of Pramipexole and Other Dopamine Agonists and the Risks of Heart Failure and Pneumonia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02236741
Other study ID # 248.672
Secondary ID
Status Completed
Phase N/A
First received September 10, 2014
Last updated September 10, 2014
Start date November 2009

Study information
Verified date September 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Observational

Clinical Trial Summary

Study to assess the risk of incident heart failure associated with the use of pramipexole compared with other dopamine agonists and additionally, to assess the risk of incident heart failure associated with the use of dopamine agonists in comparison with no use of dopamine agonist therapy

Recruitment information / eligibility
Status Completed
Enrollment 26814
Est. completion date
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 89 Years
Eligibility Inclusion Criteria:

- All patients between 40 and 89 years of age who received at least one prescription for anti-parkinsonian drugs during the period 1997-2009

Exclusion Criteria:

- Patients with a diagnosis of heart failure or with prescriptions for two or more among the digitalis, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blocker (ARB), and diuretic drug classes prior to cohort entry

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• Mirapexin® (Sifrol®)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of first-time clinical diagnosis of heart failure 150 months No
Secondary Overall rate of heart failure 150 months No
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