None listed
Conditions
Interventions
Group 1 Type of group
100 mg of MK-0633 orally, taken once a day at night, before bedtime, with or without food.
Group name:Group 2 Type of group
100 mg of placebo orally, taken once a day at night, before bedtime, with or without food.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: • The patient has successfully completed until Visit 16, including the latter, of Protocol 007. • The patient is able to understand the study procedures and agrees to participate in the study by providing written informed consent.
Exclusion criteria
Exclusion criteria: • The patient presented a serious laboratory or clinical adverse event related to the drug during their participation in Protocol 007. • The patient has presented clinically significant changes in his general medical condition since enrollment in Protocol 007 that, according to the investigator´s medical criteria, would exclude the patient from participating or completing the study. Such changes may include, but are not limited to, an unstable disease newly diagnosed clinically from the ophthalmological, neurological, hepatic, renal, connective tissue, genitourinary, gastrointestinal, cardiovascular or hematological systems. In addition, any disease that could be life-threatening (for example, ventricular arrhythmia, neoplasia [incompletely cured or treated in the last three months], poorly controlled diabetes mellitus), would prevent the patient from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of FEV1 during the study. Measure:The change from baseline in FEV1 prior to b-agonist Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Asthma attack defined by asthma symptoms during the previous 24 hours that require one of the following: Use of corticosteroids (systemic), Unscheduled visit to the doctor or emergency care clinic, Unscheduled visit to the emergency department Hospitalization Measure:Percentage of patients with an asthma attack Timepoints:During the study ; Outcome name:Asthma attack defined by asthma symptoms during the previous 24 hours that require one of the following: Use of corticosteroids (systemic), Unscheduled visit to the doctor or emergency care clinic, Unscheduled visit to the emergency department Hospitalization Measure:Time to first asthma attack Timepoints:During the study ; Outcome name:Asthma attack defined by asthma symptoms during the previous 24 hours that require one of the following: Use of corticosteroids (systemic), Unscheduled visit to the doctor or emergency care clinic, Unscheduled visit to the emergency department Hospitalization Measure:Asthma Attack Rate Timepoints:During the study ; Outcome name:Day without the use of a beta-agonist defined for a day without using a beta agonist, Measure:Percentage of days without beta-agonist Timepoints:During the study | — |
Countries
Australia, Canada, Chile, Colombia, Ecuador, Guatemala, Hungary, India, Israel, Japan, Malasya, Mexico, New Zealand, Russian Federation, United States
Contacts
Public Contactstela lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed