A Dose-Ranging Study of MK-1029 in Adults With Persistent Asthma (MK-1029-012 AM2)
Overview[ - collapse ][ - ]
| Purpose | The purpose of this adaptive-design study is to evaluate the dose-related effectiveness and safety of MK-1029, alone or in combination with montelukast, compared to placebo and to montelukast alone, in the treatment of persistent asthma in adults. |
|---|---|
| Condition | Asthma |
| Intervention | Drug: MK-1029 10 mg Drug: MK-1029 30 mg Drug: MK-1029 150 mg Drug: Montelukast 10 mg Drug: Placebo Drug: MK-1029 1 mg or 3 mg Drug: Montelukast 10 mg + MK-1029 |
| Phase | Phase 2 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT01656395 |
| First Received | July 3, 2012 |
| Last Updated | April 24, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 3, 2012 |
|---|---|
| Last Updated Date | April 24, 2014 |
| Start Date | August 2012 |
| Estimated Primary Completion Date | July 2016 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Dose-Ranging Study of MK-1029 in Adults With Persistent Asthma (MK-1029-012 AM2) |
|---|---|
| Official Title | A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Adaptive-Design, Dose-Ranging Study of MK-1029 in Adult Subjects With Persistent Asthma |
| Brief Summary | The purpose of this adaptive-design study is to evaluate the dose-related effectiveness and safety of MK-1029, alone or in combination with montelukast, compared to placebo and to montelukast alone, in the treatment of persistent asthma in adults. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Asthma |
| Intervention | Drug: MK-1029 10 mg Parts I-II: Participants will receive MK-1029 10 mg tablets taken once daily (QD) Drug: MK-1029 30 mg Parts I-II: Participants will receive MK-1029 30 mg tablets QD Drug: MK-1029 150 mg Parts I-II: Participants will receive MK-1029 150 mg tablets QD Drug: Montelukast 10 mg Parts I-II: Participants will receive Montelukast 10 mg tablets QD Other Names: SINGULAIR®Drug: Placebo Parts I-II: Participants will receive Placebo tablets QD Drug: MK-1029 1 mg or 3 mg Part II: Participants will receive either MK-1029 1 mg or 3 mg tablets (dose to be determined based on results of interim analysis from Part I) QD. Drug: Montelukast 10 mg + MK-1029 Part II: Participants will receive Montelukast 10 mg tablets QD and MK-1029 tablets (dose to be determined based on results of interim analysis from Part I) QD Other Names: SINGULAIR® |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 1475 |
| Estimated Completion Date | July 2016 |
| Estimated Primary Completion Date | July 2016 |
| Eligibility Criteria | Inclusion Criteria: - not pregnant or breastfeeding, and not planning to become pregnant during the study - history of symptoms of persistent asthma for at least one year - current use of acceptable asthma treatments and willingness to taper or discontinue these treatments; acceptable asthma treatments: - use of inhaled SABAs (e.g., albuterol/salbutamol) only "as-needed" with no use of asthma controller medications; OR - use of stable doses of low- or medium-dose inhaled corticosteroids (ICS), alone, or in combination with either a long-acting beta-agonist (LABA) or other asthma controller medications (including leukotriene receptor antagonists) and can tolerate tapering or discontinuation - no history of smoking OR no smoking within <1 year with a smoking history of ≤10 pack-years - ability to maintain a constant day/night, awake/sleep cycle - agreement to not change habitual consumption of beverages or food containing caffeine throughout the study - Body Mass Index (BMI) of 15 to 40 kg/m^2 Exclusion Criteria: - myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia within past ≤3 months - hospitalization within past ≤4 weeks - major surgical procedure within past ≤4 weeks - participation in a clinical study involving an investigational drug within past ≤4 weeks - current regular use or recent (within past ≤5 years) past abuse of alcohol (>14 drinks/week) or illicit drugs - donation of a unit of blood within past ≤2 weeks or intention to donate a unit of blood during the study - evidence of another clinically significant, active pulmonary disorder such as chronic obstructive pulmonary disease (COPD) - emergency room treatment for asthma within past ≤4 weeks or hospitalization for asthma within past ≤8 weeks - respiratory tract infection requiring antibiotic treatment within past ≤8 weeks - evidence of active, clinically significant sinus disease within past ≤1 week - history of a clinically significant psychiatric disorder, other than stable depression, within past ≤12 weeks - history of HIV - hypersensitivity or intolerance to inhaled beta-agonists, leukotriene antagonists, leukotriene synthesis inhibitors, or any of their ingredients, including lactose and galactose - clinically unstable disease of the ophthalmologic, neurological, hepatic, renal, connective tissue, genitourinary, gastrointestinal, cardiovascular or hematologic systems - current cancer or history (within past ≤5 years) of cancer (except for successfully treated basal and squamous cell carcinomas of the skin); if cancer-free for >5 years, study participation may be allowed - evidence of uncontrolled hypertension |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Toll Free Number 1-888-577-8839 |
| Location Countries | United States, Canada, Chile, Colombia, France, Germany, Guatemala, Italy, Japan, Peru, Puerto Rico, South Africa, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01656395 |
|---|---|
| Other Study ID Numbers | 1029-012 |
| Has Data Monitoring Committee | No |
| Information Provided By | Merck Sharp & Dohme Corp. |
| Study Sponsor | Merck Sharp & Dohme Corp. |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| Call for Information (Investigational Site 0045) | Mesa, Arizona, United States, 85206 Recruiting |
|---|---|
| Call for Information (Investigational Site 0150) | Scottsdale, Arizona, United States, 85251 Recruiting |
| Call for Information (Investigational Site 0052) | San Jose, California, United States, 95117 Recruiting |
| Call for Information (Investigational Site 0170) | Baltimore, Maryland, United States, 21236 Recruiting |
| Call for Information (Investigational Site 0072) | Wheaton, Maryland, United States, 20902 Recruiting |
| Call for Information (Investigational Site 0069) | White Marsh, Maryland, United States, 21162 Recruiting |
| Call for Information (Investigational Site 0061) | Portland, Oregon, United States, 97202 Recruiting |
| Call for Information (Investigational Site 0062) | Philadelphia, Pennsylvania, United States, 19104 Recruiting |
| Call for Information (Investigational Site 0071) | Pittsburgh, Pennsylvania, United States, 15213 Recruiting |
| Call for Information (Investigational Site 0148) | Boerne, Texas, United States, 78006 Recruiting |
| Call for Information (Investigational Site 9180) | San Antonio, Texas, United States, 78249 Recruiting |
| Call for Information (Investigational Site 0038) | Waco, Texas, United States, 76712 Recruiting |
| Merck Canada | Kirkland, Quebec, Canada, H9H 3L1 Contact: Medical Information Centre / Centre de l'information medicale de Merck Canada | 514-428-8600 / 1-800-567-2594Recruiting |
| Merck Sharp & Dohme (I.A.) Corp. | Santiago, Chile Contact: Maria Elena Azara Hernandez | 56 2 6558958Recruiting |
| MDS Colombia SAS | Bogota, Colombia Contact: Francesca Carvajal | 57 1219109011090Recruiting |
| MSD France | Paris, France Contact: Dominique Blazy | 33 147548990Recruiting |
| Merck Sharp & Dohme GmbH | Haar, Germany Contact: German Medical Information Center | 49 800 673 673 673Recruiting |
| MSD CARD | Guatemala, Guatemala Contact: Soraya Cedraro | 507-282-7200Recruiting |
| MSD Italia S.r.l. | Rome, Italy Contact: Patrizia Nardini | 39 06 361911Recruiting |
| MSD K.K. | Chiyoda-Ku, Tokyo, Japan, 102-8667 Contact: Japan Call Center | 81-3-6272-1957Recruiting |
| Merck Sharp & Dohme, Peru S.R.L. | Lima, Peru Contact: Oscar Espinoza | (51-1) 411-5100Recruiting |
| Merck Sharp & Dohme (I.A.) Corp. | Carolina, Puerto Rico Contact: Felipe Arbelaez | (787) 474-8200Recruiting |
| MSD (Pty) LTD South Africa | Midrand, South Africa Contact: Khanyi Mzolo | 27 11 655 3140Recruiting |
| Merck Sharp & Dohme Ltd. | Hoddesdon, United Kingdom Contact: Paul Robinson | 44 1992452396Recruiting |