Status:
COMPLETED
Efficacy, Safety, and Pharmacokinetics of QAW039
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Persistent Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.
Eligibility Criteria
Inclusion
- Patients with a medical history of mild to moderate persistent allergic asthma.
- Patients must weigh at least 45 kg to participate in the study, and must have abody mass index (BMI) of \>17 kg/m2.
- Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception
Exclusion
- Women of child-bearing potential.
- Smokers defined as history of smoking in the previous 6 months or a smoking history of more than 10 pack years, a pack year being defined as smoking the equivalent of 20 cigarettes - a pack - every day for the period of 1 year
- Patients with severe persistent asthma
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT01253603
Start Date
November 1 2010
End Date
September 1 2011
Last Update
December 19 2020
Active Locations (26)
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1
Novartis Investigative Site
Encinitas, California, United States, 92024
2
Novartis Investigative Site
Huntington Beach, California, United States, 92647
3
Novartis Investigative Site
Los Angeles, California, United States, 90025
4
Novartis Investigative Site
Los Angeles, California, United States, 90048