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

December 2, 2010 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
    • Florida
      • Miami, Florida, United States
        • Research Site
    • Texas
      • San Antonio, Texas, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZD6140
Drug: AZD6140
single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Scheduled times during the 3 days after the study drug is taken

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Scheduled times during the 3 days after the study drug is taken

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

August 12, 2008

First Submitted That Met QC Criteria

August 12, 2008

First Posted (Estimate)

August 13, 2008

Study Record Updates

Last Update Posted (Estimate)

December 3, 2010

Last Update Submitted That Met QC Criteria

December 2, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5130C00015
  • AZD6140/Renal Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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