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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00733265 |
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Date of registration:
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12/08/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers
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Scientific title:
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Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00733265 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Kathleen Butler, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients must have severe kidney disease
- Subjects who are matched to the kidney disease patients in terms of weight, age, and
sex must have normal kidneys
- All women must be post-menopausal (no longer menstruating) or surgically sterile
Exclusion Criteria:
- Patients requiring dialysis
- History of allergy to aspirin or clopidogrel
- Have increased bleeding risk (for instance uncontrolled high blood pressure or a
recent major injury)
- Recent history of fainting or light-headedness
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Renal Impairment
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Intervention(s)
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Drug: AZD6140
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Primary Outcome(s)
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Blood levels of AZD6140 in patients with severe kidney disease compared to volunteers with normal kidneys
[Time Frame: Scheduled times during the 3 days after the study drug is taken]
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Secondary Outcome(s)
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Measure the effect of AZD6140 on how well blood clots in patients with severe kidney disease compared to subjects with normal kidneys
[Time Frame: Scheduled times during the 3 days after the study drug is taken]
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Safety and tolerability of AZD6140 in patients with severe kidney disease compared to subjects with normal kidneys
[Time Frame: Screening through completion of the study]
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Secondary ID(s)
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D5130C00015
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AZD6140/Renal Study
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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