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MULTICENTRIC STUDY, RANDOM SELECTION, DOUBLE-BLIND, CROSSBREAKING, COMPARING THE EFFECT OF L-454560 AND PLACEBO IN ADULT PATIENTS WITH CHRONIC ASTHMA.

MULTICENTRIC STUDY, RANDOM SELECTION, DOUBLE-BLIND, CROSSBREAKING, COMPARING THE EFFECT OF L-454560 AND PLACEBO IN ADULT PATIENTS WITH CHRONIC ASTHMA.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-065-02
Enrollment
8
Registered
2002-10-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

None listed

Interventions

L-454560 Type of group
15 mg of L-454560 will be administered with placebo in adult patients with chronic asthma.

Sponsors

MERCK SHARP & DOHME PERU S.R.L.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The patient understands the study procedures and agrees to participate as indicated by signing the appropriate Informed Consent Document. The patient has a medical history (of at least one year) consistent with persistent or intermittent asthma symptoms that include, but are not limited to; dyspnea, wheezing, tightness in the chest, cough and sputum production. The patient has a FEVi, while not using p-agonists for six hours, between 50% and 80% of the predicted value, documented at least twice during Visits 1, 2, and / or 3.

Exclusion criteria

Exclusion criteria: In the opinion of the investigator, the patient is mentally or legally incapacitated, which prevents the informed consent from being obtained; He is unable to read. The patient shows significant abnormalities in the physical examination of Visit 1 or in laboratory measurements. The patient has a recent history (within 3 months of Visit 1) of a clinically symptomatic psychiatric disorder.

Design outcomes

Primary

MeasureTime frame
Outcome name:FEV1 Measure:The FEV1 measured at the end of the interval of a daily dose. Timepoints:14 day

Secondary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated

Countries

Australia, Brazil, Colombia, Hungary, Israel, United States

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results

None listed

Source: REPEC (via WHO ICTRP)