A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, CROSSOVER STUDY OF MK-1029 IN ADLTS SUBJECTS WITH PERSISTENT ASTHMA WHO REMAIN UNCONTROLLED WHILE BEING MAINTAINED ON MONTELUKAST.
- Registration Number
- PER-098-12
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 33
VISIT 1
1. SUBJECT IS A FEMALE OR MALE SUBJECT BETWEEN 18 AND 75 YEARS OF AGE.
2. SUBJECT IS NOT PREGNANT (AS EVIDENCED BY NEGATIVE SERUM PREGNANCY TEST FOR SUBJECTS OF CHILDBEARING POTENTIAL) OR BREASTFEEDING AND DOES NOT PLAN TO BECOME PREGNANT FOR THE DURATION OF THE STUDY AND POST STUDY FOLLOW-UP PERIOD.
3. A SUBJECT WHO IS OF REPRODUCTIVE POTENTIAL AGREES TO REMAIN ABSTINENT OR USE (OR HAVE THEIR PARTNER USE) 2 ACCEPTABLE METHODS OF BIRTH CONTROL WITHIN THE PROJECTED DURATION OF THE STUDY. ACCEPTED METHODS OF BIRTH CONTROL ARE: INTRAUTERINE DEVICE (IUD), DIAPHRAGM WITH SPERMICIDE, CONTRACEPTIVE SPONGE, CONDOM, VASECTOMY, HORMONAL CONTRACEPTIVES.
A FEMALE SUBJECT WHO IS NOT OF REPRODUCTIVE POTENTIAL IS ELIGIBLE WITHOUT REQUIRING THE USE OF CONTRACEPTION. A FEMALE SUBJECT WHO IS NOT OF REPRODUCTIVE POTENTIAL IS DEFINED AS: ONE WHO HAS EITHER 1) REACHED NATURAL MENOPAUSE (DEFINED AS 6 MONTHS OF SPONTANEOUS AMENORRHEA WITH SERUM FSH LEVELS IN THE POSTMENOPAUSAL RANGE AS DETERMINED BY THE LABORATORY, OR 12 MONTHS OF SPONTANEOUS AMENORRHEA), 2) 6 WEEKS POST SURGICAL BILATERAL OOPHORECTOMY WITH OR WITHOUT HYSTERECTOMY, OR 3) BILATERAL TUBAL LIGATION.
VISIT 1
1. SUBJECT IS, IN THE OPINION OF THE INVESTIGATOR, MENTALLY OR LEGALLY INCAPACITATED PREVENTING INFORMED CONSENT FROM BEING OBTAINED, UNABLE TO READ OR COMPREHEND WRITTEN MATERIAL, OR UNABLE TO COMPLY WITH THE STUDY PROCEDURES OR PROTOCOL.
2. SUBJECT HAS A RECENT HISTORY (≤ 3 MONTHS) OF MYOCARDIAL INFARCTION, CONGESTIVE HEART FAILURE, OR UNCONTROLLED CARDIAC ARRHYTHMIA PRIOR TO VISIT 1.
3. SUBJECT IS HOSPITALIZED OR HAS BEEN HOSPITALIZED IN THE 4 WEEKS PRIOR TO VISIT 1.
4. SUBJECT INTENDS TO MOVE OR ANTICIPATES MISSING ANY CLINIC VISIT DAYS.
5. SUBJECT HAS UNDERGONE ANY MAJOR SURGICAL PROCEDURE WITHIN 4 WEEKS PRIOR TO VISIT 1.
6. SUBJECT HAS PARTICIPATED IN A CLINICAL TRIAL INVOLVING AN INVESTIGATIONAL DRUG WITHIN THE 4 WEEKS PRIOR TO VISIT 1.
7. SUBJECT IS CURRENTLY A REGULAR USER OR A RECENT PAST ABUSER (WITHIN THE PAST 5 YEARS) OF ALCOHOL (> 14 DRINKS/WEEK) OR ILLICIT DRUGS.
8. SUBJECT HAS DONATED A UNIT OF BLOOD WITHIN 2 WEEKS PRIOR TO VISIT 1 OR INTENDS TO DONATE A UNIT OF BLOOD AT ANY TIME DURING THE COURSE OF THIS STUDY.
PULMONARY
9. SUBJECT HAS EVIDENCE OF ANOTHER CLINICALLY SIGNIFICANT, ACTIVE PULMONARY DISORDER SUCH AS BRONCHIECTASIS OR COPD DOCUMENTED BY HISTORY, PHYSICAL EXAMINATION, OR CHEST X-RAY.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method