Efficacy, Safety and Pharmacokinetics of QAV680 Versus Placebo in Patients With Asthma

NCT ID: NCT01103037

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-09-30

Brief Summary

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This study will assess the safety and efficacy of QAV680 in patients with mild to moderate asthma

Detailed Description

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Conditions

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Asthma

Keywords

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Mild Moderate Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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QAV680

Group Type EXPERIMENTAL

QAV680

Intervention Type DRUG

QAV680 500 mg (5 x 100 mg capsules) four times per day

QAV680 Placebo

Group Type PLACEBO_COMPARATOR

QAV680 Placebo

Intervention Type DRUG

Placebo to QAV680 5 capsules four times per day

Interventions

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QAV680

QAV680 500 mg (5 x 100 mg capsules) four times per day

Intervention Type DRUG

QAV680 Placebo

Placebo to QAV680 5 capsules four times per day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with moderate persistent asthma

Exclusion Criteria

* Smokers
* Any significant disease or illness, other than asthma
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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West Coast Clinical Trials

Cypress, California, United States

Site Status

American Health Research

Charlotte, North Carolina, United States

Site Status

North Carolina Clinical Research

Raleigh, North Carolina, United States

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Wiesbaden, , Germany

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Countries

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United States Germany Russia

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6683

Results for CQAV680A2201E1 from the Novartis Clinical Trials website

Other Identifiers

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2009-017267-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQAV680A2201E1

Identifier Type: -

Identifier Source: org_study_id