Study Complete
Sponsor ID
20080615

AMG 853 Phase 2 Study in Subjects with Inadequately Controlled Asthma

Sponsor ID
20080615
Clinicaltrials.gov ID
NCT01018550
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.

Additional Study Details

Phase
Phase 2
Product
vidupiprant
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
397
Additional Study Details

Protocol Summary

Primary Outcome Measures

The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.

Timeframe: Baseline to Week 12

Secondary Outcome Measures

Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA)

Timeframe: Baseline to Week 12

Evaluate the efficacy of AMG 853 as measured by daily symptom score (aggregate/night and individual symptoms; and symptom free days)

Timeframe: Baseline to Week 12

Evaluate the efficacy of AMG 853 as measured by pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1)

Timeframe: Baseline to Week 12

Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR)

Timeframe: Baseline to Week 12

Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ)

Timeframe: Baseline to Week 12

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.