Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00733265
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : December 3, 2010
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE August 12, 2008
First Posted Date  ICMJE August 13, 2008
Last Update Posted Date December 3, 2010
Study Start Date  ICMJE February 2007
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2008)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers
Official Title  ICMJE Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Renal Impairment
Intervention  ICMJE Drug: AZD6140
single oral dose
Study Arms  ICMJE Experimental: AZD6140
Intervention: Drug: AZD6140
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 12, 2008)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT00733265
Other Study ID Numbers  ICMJE D5130C00015
AZD6140/Renal Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jay Horrow, MD, Medical Science Director, AZD6140, AstraZeneca Pharmaceuticals
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kathleen Butler, MD AstraZeneca
PRS Account AstraZeneca
Verification Date December 2010

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