WHO ICTRP trial

A double-blind, placebo-controlled efficacy (as assessed by post-bronchodilator…

EUCTR2006-002525-23-GB · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2006-002525-23-GB
Public title A double-blind, placebo-controlled efficacy (as assessed by post-bronchodilator FEV1) and safety study of 5 mg RO3300074 once-daily for 2 years in subjects with smoking-related, moderate-to-severe COPD with emphysema receiving concurrent optimal COPD drug therapy.
Scientific title A double-blind, placebo-controlled efficacy (as assessed by post-bronchodilator FEV1) and safety study of 5 mg RO3300074 once-daily for 2 years in subjects with smoking-related, moderate-to-severe COPD with emphysema receiving concurrent optimal COPD drug therapy.
Primary sponsor F. Hoffmann-La Roche Ltd
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Czech Republic;Hungary;Latvia;Iceland;Italy;United Kingdom
Conditions symptomatic smoking-related emphysema in ex-smokers MedDRA version: 8.1 Level: LLT Classification code 10014561 Term: Emphysema
Interventions Product Name: Not applicable Product Code: RO3300074 Pharmaceutical Form: Capsule, soft INN or Proposed INN: Not assigned Current Sponsor code: RO3300074 Concentration unit: mg milligram(s) Concentration type: equal Concentration number…
Registration date Sep 10, 2006
Target size 480
Secondary IDs NB19751C
Registry page clinicaltrialsregister.eu

At a glance

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