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

Phase 1

• Conditions: Stable angina pectoris; MedDRA version: 8.0Level: LLTClassification code 10049194

• Registration Number: EUCTR2005-002456-18-SK
• Lead Sponsor: Astellas Pharma Europe B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-13
• Last Update Posted: 27 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified