Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00733265
First received: August 12, 2008
Last updated: December 2, 2010
Last verified: December 2010

August 12, 2008
December 2, 2010
February 2007
September 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00733265 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers
Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Renal Impairment
Drug: AZD6140
single oral dose
Experimental: AZD6140
Intervention: Drug: AZD6140
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00733265
D5130C00015, AZD6140/Renal Study
No
Jay Horrow, MD, Medical Science Director, AZD6140, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Study Director: Kathleen Butler, MD AstraZeneca
AstraZeneca
December 2010

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