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

NCT ID: NCT00733265

Last Updated: 2010-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-09-30

Brief Summary

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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

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Conditions

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Renal Impairment

Keywords

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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AZD6140

Group Type EXPERIMENTAL

AZD6140

Intervention Type DRUG

single oral dose

Interventions

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AZD6140

single oral dose

Intervention Type DRUG

Eligibility 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Kathleen Butler, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Phoenix, Arizona, United States

Site Status

Research Site

Anaheim, California, United States

Site Status

Research Site

Miami, Florida, United States

Site Status

Research Site

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21960668 (View on PubMed)

Other Identifiers

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AZD6140/Renal Study

Identifier Type: -

Identifier Source: secondary_id

D5130C00015

Identifier Type: -

Identifier Source: org_study_id