A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House blinding Conditions of MK-0633 in Patients With COPD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005096-17-LT

Enrollment

250

Registered

2006-10-18

Start date

2006-11-30

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 8.1 Level: LLT Classification code 10010952 Term: COPD

Interventions

Product Name: MK-0633 Product Code: MK-0633 Pharmaceutical Form: Capsule* Current Sponsor code: MK-0633 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceu

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Patients' post Beta-agonist spirometry measurements at Visit 1 meet all of thefollowing COPD study criteria: (1) FEV1/FVC ratio =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient hasevidence of another clinically significant, active pulmonary disorder such as bronchiectasis or asthma documented by history, physical examination, or chest x-ray

Design outcomes

Primary

Measure	Time frame
Main Objective: (1) To investigate the treatment effect of MK-0633, compared with placebo, on the pre-dose (trough) FEV1, measured over a 12-week treatment period in patients with Chronic Obstructive Pulmonary Disease (COPD). (2) To evaluate the safety and tolerability of MK-0633 in patients with COPD;Secondary Objective: To investigate the treatment effect of MK-0633, compared with placebo, on the secondary endpoints of overall daytime symptoms score, post-dose FEV1, total daily ß-agonist use, dyspnea rating (Transition Dyspnea Index) and CRQ score, measured over a 12-week treatment period in patients with COPD.;Primary end point(s): To investigate the treatment effect of MK-0633, compared with placebo, on the pre-dose (trough) FEV1, measured over a 12-week treatment period in patients with Chronic Obstructive Pulmonary Disease (COPD)	—

Measure

Time frame

Main Objective: (1) To investigate the treatment effect of MK-0633, compared with placebo, on the pre-dose (trough) FEV1, measured over a 12-week treatment period in patients with Chronic Obstructive Pulmonary Disease (COPD). (2) To evaluate the safety and tolerability of MK-0633 in patients with COPD;Secondary Objective: To investigate the treatment effect of MK-0633, compared with placebo, on the secondary endpoints of overall daytime symptoms score, post-dose FEV1, total daily ß-agonist use, dyspnea rating (Transition Dyspnea Index) and CRQ score, measured over a 12-week treatment period in patients with COPD.;Primary end point(s): To investigate the treatment effect of MK-0633, compared with placebo, on the pre-dose (trough) FEV1, measured over a 12-week treatment period in patients with Chronic Obstructive Pulmonary Disease (COPD)

—

Countries

Lithuania

Outcome results

None listed

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