Safety and Efficacy of TAK-442 in Subjects With Acute Coronary Syndromes

Summary

The purpose of this study is to determine the safety and tolerability of multiple doses of TAK-442once daily, (QD) or twice daily (BID), in subjects with acute coronary syndrome (unstable angina, myocardial infarction).

Conditions

• Acute Coronary Syndrome

Interventions

DRUG

TAK-442

Stage I: TAK-442 10 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.

DRUG

TAK-442

Stage I: TAK-442 20 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.

DRUG

TAK-442

Stage I: TAK-442 40 mg, capsules, orally, once daily and standard care for recurrent ischemic events for up to 24 weeks.

DRUG

TAK-442

Stage II: TAK-442 40 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.

DRUG

TAK-442

Stage II: TAK-442 80 mg, capsules, orally, once daily and standard care for recurrent ischemic events for up to 24 weeks.

DRUG

TAK-442

Stage II: TAK-442 80 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.

DRUG

TAK-442

Stage III: TAK-442 160 mg, capsules, orally, once daily and standard care for recurrent ischemic events for up to 24 weeks.

DRUG

TAK-442

Stage III: TAK-442 120 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.

DRUG

Placebo

Stages I, II \& III: TAK-442 placebo-matching capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.

Sponsors & Collaborators

• Takeda

  lead INDUSTRY

Principal Investigators

• Executive Medical Director Clinical Science · Takeda

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-03-31

Primary Completion

2010-06-30

Completion

2010-06-30

Countries

• United States
• Argentina
• Belgium
• Brazil
• Bulgaria
• Canada
• Chile
• Estonia
• Germany
• Hungary
• India
• Netherlands
• Peru
• Romania
• Russia
• Serbia
• South Africa
• South Korea
• United Kingdom

Study Locations