A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis
NCT00730145
ABOUT THIS STUDY
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- Patients receiving regular hemodialysis
- Male or female patients 18 to 65 years
- Severe heart failure
- Renal transplant or renal allograft
- Illicit drug use (with the exception of prescribed sedatives)
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Descriptive Information | ||||
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Brief Title ICMJE | A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis | |||
Official Title ICMJE | A Phase I, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD-0332334 In Subjects Receiving Chronic Hemodialysis | |||
Brief Summary |
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Detailed Description | Assess the elimination of PD-0332334 from the blood with hemodialysis | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) | |||
Condition ICMJE |
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Intervention ICMJE | Drug: PD-0332334
A single, 50 mg oral dose (2 capsules) of PD-0332334 will be administered to each hemodialysis subject Other Name: imagabalin | |||
Study Arms ICMJE | Experimental: PD-0332334
Intervention: Drug: PD-0332334 | |||
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 | |||
Actual Enrollment ICMJE | 8 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | January 2009 | |||
Actual Primary Completion Date | January 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00730145 | |||
Other Study ID Numbers ICMJE | A5361032 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | February 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |