A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PRELIMINARY EFFICACY OF A FOUR-WEEK TREATMENT WITH YM758 IN SUBJECTS WITH STABLE ANGINA. - IRIS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002456-18-SK

Enrollment

210

Registered

2006-03-13

Start date

2006-04-21

Completion date

Unknown

Last updated

2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable angina pectoris MedDRA version: 8.0 Level: LLT Classification code 10049194

Interventions

Product Name: YM758 Product Code: YM758 Pharmaceutical Form: Film-coated tablet Current Sponsor code: YM758 monophosphate Other descriptive name: IFI-930A, YM222758 monophosphate Concentration unit: m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - male or female aged 18 years and older, 75 y. and younger - at least 3 months chronic stable effort induced angina relieved by rest or nitroglycerin - analysable ST segment on 12-lead ECG - heart rate 5O bpm. and more at rest - two positive reproductible exercise tolerance tests during the screening period and on Day 0. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - unstable angina, rest angina, Prinzmetal angina, significant valvular and pericardial disease, history or presence of atrial fibrillation (flutter, sick sinus syndrome, 2nd or 3rd degree atrioventricular block, congestive heart failure NYHA class III-IV. - current use of antifungal medication except of short acting nitrates - current use if drugs that should interfere with ST-segment changes - current use of CYP3A4 inhibitors and inducers - history or presence of clinically relevant ophtalmologic diseases - impaired liver or renal functions - uncontrolled intercurrent illness

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the safety and tolerability of different oral doses of YM758 in subjects with stable angina.;Secondary Objective: To evaluate the efficacy and pharmacodynamics of YM758. To explore the pharmacokinetics of YM 758 in the target population.;Primary end point(s): - frequency,severity, and nature of adverse events - biochemical, haematological, and urine analysis tests - vital signs, 12-lead ECG, physical examination, ophtalmologic examinations results	—

Measure

Time frame

Main Objective: To assess the safety and tolerability of different oral doses of YM758 in subjects with stable angina.;Secondary Objective: To evaluate the efficacy and pharmacodynamics of YM758. To explore the pharmacokinetics of YM 758 in the target population.;Primary end point(s): - frequency,severity, and nature of adverse events - biochemical, haematological, and urine analysis tests - vital signs, 12-lead ECG, physical examination, ophtalmologic examinations results

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Countries

Slovakia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026