A DOUBLE BLIND, CONTROLLED WITH PLACEBO EXTENSION STUDY OF MK-0633 CARRIED OUT IN ADULT PATIENTS WITH CHRONIC ASTHMA (EXTENSION TO PROTOCOL 007)

Not Applicable

• Conditions: -J45; J45

• Registration Number: PER-147-08
• 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: 2008-12-16
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Measurement of FEV1 during the study.<br>Measure:The change from baseline in FEV1 prior to b-agonist<br>Timepoints:During the study<br>