OPEN, CONTROLLED EXTENSION STUDY IN CHRONIC ASTHMA TO COMPARE THE EFFECT OF MONTELUKAST WITH PLACEBO IN PATIENTS FROM 2 TO 5 YEARS OF AGE

Not Applicable

• Conditions: -J458 Mixed asthma; Mixed asthma; J458

• Registration Number: PER-049-00
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-08-15
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• The patient arrived satisfactorily until Visit 24 of Protocol 072-11.
• The parent / legal guardian accepts the patient´s participation in the study as indicated by the signature of the parent / legal guardian on the consent form. The patient and the parent / guardian are willing to comply with the procedures and both the patient and the parent / guardian can make the scheduled clinical visits.

Exclusion Criteria

• The consent of the parent or guardian can not be obtained.
• The patient is hospitalized.
• The patient suffered a serious or adverse clinically important experience that is still present at Visit 24 of Protocol 072-11.
• The patient experiences significant changes from the clinical point of view in his general medical condition since he enrolled in Protocol 072-11.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Physical exam including neurological exam<br>Vital signs<br>Blood Biochemistry<br>BUN (nitrogen of blood urea)<br>Creatinine<br>Total bilirubin<br>SGOT (glutamic oxaloacetic serum transaminase) (AST)<br>SGPT (serum pyruvate glutamic transaminase) (ALT)<br>Alkaline phosphatase<br>Glucose<br>Sodium<br>Potassium<br>Chloride<br>Baking soda<br>Calcium<br>Phosphate<br>Measure:Safety<br>Timepoints:Visits 26, 28 y 30<br>