Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers
2 other identifiers
interventional
24
1 country
4
Brief Summary
The main purpose of this study is to examine how AZD6140 affects patients with severe kidney disease compared to volunteers with normal kidneys. Subjects in the study will receive one dose of AZD6140.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2007
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 12, 2008
CompletedFirst Posted
Study publicly available on registry
August 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedDecember 3, 2010
December 1, 2010
1.6 years
August 12, 2008
December 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood levels of AZD6140 in patients with severe kidney disease compared to volunteers with normal kidneys
Scheduled times during the 3 days after the study drug is taken
Secondary Outcomes (2)
Safety and tolerability of AZD6140 in patients with severe kidney disease compared to subjects with normal kidneys
Screening through completion of the study
Measure the effect of AZD6140 on how well blood clots in patients with severe kidney disease compared to subjects with normal kidneys
Scheduled times during the 3 days after the study drug is taken
Study Arms (1)
AZD6140
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (4)
Research Site
Phoenix, Arizona, United States
Research Site
Anaheim, California, United States
Research Site
Miami, Florida, United States
Research Site
San Antonio, Texas, United States
Related Publications (1)
Butler K, Teng R. Pharmacokinetics, pharmacodynamics, and safety of ticagrelor in volunteers with severe renal impairment. J Clin Pharmacol. 2012 Sep;52(9):1388-98. doi: 10.1177/0091270011415526. Epub 2011 Sep 29.
PMID: 21960668DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kathleen Butler, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 12, 2008
First Posted
August 13, 2008
Study Start
February 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
December 3, 2010
Record last verified: 2010-12