Observational Study of Pergolide Mesylate and Cardiac Valvulopathy

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00311532
First received: April 5, 2006
Last updated: July 16, 2007
Last verified: July 2007

April 5, 2006
July 16, 2007
March 2006
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Complete list of historical versions of study NCT00311532 on ClinicalTrials.gov Archive Site
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Observational Study of Pergolide Mesylate and Cardiac Valvulopathy
Observational Study to Determine the Incidence of New-Onset Valvulopathy in Patients Treated With Pergolide as Second-Line Therapy for Parkinson's Disease

The primary objective of this study is to estimate the incidence of new-onset valvulopathy, determined by baseline and follow-up echocardiograms, in patients with Parkinson's Disease who are receiving pergolide as second-line therapy.

The secondary objective of the study is to estimate the prevalence of valvulopathy, as determined by baseline echocardiograms, among all patients who have Parkinson's Disease and are being considered for pergolide as second-line therapy.

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Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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Parkinson Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
May 2007
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Inclusion Criteria:

  • Male or female, age 18 and older with a diagnosis of Parkinson's Disease
  • Receiving pergolide as second-line therapy as prescribed by Summary of Product Characteristics
  • Willing to participate and sign a consent to release medical information
  • Have had an echocardiogram within 3 months of initiation of pergolide therapy with no evidence of cardiac valvulopathy

Exclusion Criteria:

  • There are no exclusion criteria for this study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Belgium,   Italy,   Germany
 
NCT00311532
10245, B4G-MC-B001
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Eli Lilly and Company
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
July 2007

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