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Study to Assess the Effect of Ticagrelor on Coronary Blood Flow in Healthy Male Subjects.

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Blood Flow Speed; Coronary Flow Velocity

Intervention: AZD6140 (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Jay Horrow, MD, Study Director, Affiliation: AstraZeneca
Marianne Hartford, MD, Principal Investigator, Affiliation: CTC, Göteborg
Mirjana Kujacic, MD PhD, Study Chair, Affiliation: AstraZeneca, Mölndal Sweden

Summary

The purpose of this study is to determine if Ticagrelor increases the Adenosin induced coronary blood flow velocity.

Clinical Details

Official title: A Randomized, Double-blind, Placebo Controlled, Crossover, Single Centre Phase I Study to Assess the Effect of Ticagrelor on Adenosine-induced Coronary Blood Flow Velocity in Healthy Male Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Assess the effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity response by estimating the change in area under the adenosine dose response curve before and after study drug.

Assess the effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity response by estimating the change in area under the adenosine dose response curve before and after study drug.

Secondary outcome:

Effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity by estimating the change in area under the adenosine dose response curve before and after infusion of theophylline.

Difference in basal blood flow (in the absence of adenosine) between Ticagrelor and placebo conditions before and after infusion of theophylline.

Difference in basal blood flow (in the absence of adenosine) between Ticagrelor and placebo conditions before and after infusion of theophylline.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Suitable for ECG recording of CBFV and have no adverse reaction to adenosine

challenge

- Have a body mass index between 18 and 30 kg/m2

Exclusion Criteria:

- History of clinically significant disease or disorder.

- Abnormal vital signs

Locations and Contacts

Research Site, Uppsala, Sweden
Additional Information

Starting date: December 2010
Last updated: February 10, 2012

Page last updated: August 23, 2015

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