Study of ONO-1101 in Patients Scheduled for Multi-Slice Computed Tomography (CT)

Ono Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Drug: ONO-1101

Study type: Interventional

Funder types: Industry

Identifiers

NCT00924586

ONO-1101-27

Details and patient eligibility

About

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

Enrollment: 258 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 20 years old
• Heart rate ≥ 70beats/min and ≤ 90beats/min at entering the CT room and just before dosing organic nitrates.

Exclusion criteria

• Previous allergic reactions to contrast agent
• Renal failure
• Asthma

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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258 participants in 2 patient groups, including a placebo group

P

Placebo Comparator group

Treatment:

Drug: ONO-1101

Drug: ONO-1101

E

Experimental group

Treatment:

Drug: ONO-1101

Drug: ONO-1101