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Study of ONO-1101 in Patients Scheduled for Coronary Angiography

NCT00560209 — Phase 2, Completed, 183 participants, Ono Pharmaceutical Co., Ltd.
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Study of ONO-1101 in Patients Scheduled for Coronary Angiography, a Double-Blind, Randomized,Placebo-Controlled, Parallel Group, Multi-Center Study

RegistryNCT00560209
StatusCompleted
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: double, diagnostic
Enrollment183 (Actual)
SponsorOno Pharmaceutical Co., Ltd. (Industry)
ConditionsCoronary Artery Disease
InterventionsONO-1101 (Drug)
Datesstart 2007-11-01, primary completion 2008-11-01, first posted 2007-11-19, last updated 2012-06-13
Locations1 site in Japan

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-Summary

The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for coronary angiography, in a double-blind, randomized, placebo-controlled, parallel group, multi-center study.

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+Arms and interventions

ArmTypeInterventionsDescription
PPlacebo comparatorDrug: ONO-1101
E2ExperimentalDrug: ONO-1101
E1ExperimentalDrug: ONO-1101
  • ONO-1101 (Drug): placebo for 1 minute IV
  • ONO-1101 (Drug): 0.06 mg/kg for 1 minute IV
  • ONO-1101 (Drug): 0.125 mg/kg for 1 minute IV

+Outcome measures

Primary outcomes

  • CT image quality [one day]

Secondary outcomes

  • Heart rate [For less than one month]
  • CT diagnostic accuracy [For less than one month]

+Eligibility

Sex: All, ages: 20 Years to any

Inclusion Criteria:

* 20 years of age or older
* Heart rate less than 90 beats/min and more than 70 beats/min at entering the CT room

Exclusion Criteria:

* Previous allergic reactions to contrast agent
* Renal failure
* Asthma
* Concomitant beta-receptor blocking agent

+Locations (1)

FacilityCityCountryStatus
Kinki RegionKinkiJapan

+Publications

  • Results publication: Jinzaki M, Hirano M, Hara K, Suzuki T, Yamashina A, Ikari Y, Iino M, Yamaguchi T, Kuribayashi S. A randomized, double-blind, placebo-controlled, phase II dose-finding study of the short acting beta1-blocker, landiolol hydrochloride, in patients with suspected ischemic cardiac disease. Int J Cardiovasc Imaging. 2013 Jun;29 Suppl 1(Suppl 1):7-20. doi: 10.1007/s10554-013-0253-3. Epub 2013 Jun 20. PMID 23784548

+Investigators

My Notes