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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Renal Impairment
 Drug: AZD6140
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Ticagrelor
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: February 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD6140 Drug: AZD6140
single oral dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733265

Locations
United States, Arizona
Research Site
Phoenix, Arizona, United States
United States, California
Research Site
Anaheim, California, United States
United States, Florida
Research Site
Miami, Florida, United States
United States, Texas
Research Site
San Antonio, Texas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Kathleen Butler, MD AstraZeneca
  More Information

No publications provided

Responsible Party: Jay Horrow, MD, Medical Science Director, AZD6140, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00733265     History of Changes
Other Study ID Numbers: D5130C00015, AZD6140/Renal Study
Study First Received: August 12, 2008
Last Updated: December 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Renal Impairment

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
 Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013