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Observational Study of Pergolide Mesylate and Cardiac Valvulopathy
This study has been completed.

First Received on April 5, 2006.   Last Updated on July 16, 2007   History of Changes
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00311532
  Purpose

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.


Condition
Parkinson Disease

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
Official Title: Observational Study to Determine the Incidence of New-Onset Valvulopathy in Patients Treated With Pergolide as Second-Line Therapy for Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome
MedlinePlus related topics: Heart Valve Diseases Parkinson's Disease
Drug Information available for: Pergolide Pergolide mesylate
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Estimated Enrollment: 200
Study Start Date: March 2006
Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311532

Locations
Belgium
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Antwerpen, Belgium, 2020
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Edegem, Belgium, 2650
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gent, Belgium, 9000
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Montigny Le Tilleul, Belgium, 6110
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wilrijk, Belgium, 2610
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aix En Provence, France, 13100
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Clermont-Ferrand, France, 63003
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dijon, France, 21000
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Montpellier, France, 34295
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Strasbourg, France, 67091
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bergisch Gladbach, Germany, D-51465
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ulm, Germany, 89087
Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ancona, Italy, 60020
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Parma, Italy, 43100
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00311532     History of Changes
Other Study ID Numbers: 10245, B4G-MC-B001
Study First Received: April 5, 2006
Last Updated: July 16, 2007
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Heart Valve Diseases
Parkinson Disease
Heart Diseases
Cardiovascular Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Movement Disorders
Neurodegenerative Diseases
Pergolide
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012



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