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Pharmacokinetics of CRD007 in Patients With Abdominal Aorta Aneurisms.

NCT ID: NCT01723618

Last Updated: 2012-11-29

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2012-11-30

Brief Summary

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The purpose of the study is to determine the plasma levels of CRD007 in patients with abdominal aortic aneurysms after the administration of single doses of tablets containing 10, 25 and 40 mg CRD007.

Detailed Description

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Conditions

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Abdominal Aortic Aneurisms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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CRD007 10 mg

CRD007, 10 mg tablet, single dose

Group Type EXPERIMENTAL

CRD007

Intervention Type DRUG

CRD007 25 mg

CRD007, 25 mg tablet, single dose

Group Type EXPERIMENTAL

CRD007

Intervention Type DRUG

CRD007 40 mg

CRD007, 40 mg tablet, single dose

Group Type EXPERIMENTAL

CRD007

Intervention Type DRUG

Interventions

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CRD007

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Infra-renal abdominal aortic aneurysm

Exclusion Criteria

* Significant concurrent disease or medical conditions that are deemed to interfere with the pharmacokinetics or the safety of CRD007 conduct of the trial
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RSPR Pharma AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nikolaj F Groendal, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Vascular Surgery Viborg Hospital Heiberg Allé 4 DK-8800 Viborg Denmark

Locations

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Department of Vascular Surgery Viborg Hospital

Viborg, Denmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Cardoz-005

Identifier Type: -

Identifier Source: org_study_id