None listed
Conditions
Interventions
Group 1 Type of group
One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
Group name:Group 5 Type of group
One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • The patient is> 18 years old and 120 mm Hg and 85 mm Hg and 7.0% and 120 mm Hg and 85 mm Hg and <100 mm Hg. • The absolute difference in the patient´s average SiDBP should be <7 mm Hg between 2 consecutive visits (ie, Visit 4 and the previous visit) at least 7 days away.
Exclusion criteria
Exclusion criteria: • The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. • The patient has an FPG> 270 mg / dL (14.99 mmol / L) on Visit 1 or on Visit 3 or Combined Visit 2/3. • The patient has a known or suspected secondary hypertension of any etiology, such as unilateral or bilateral nephropathy, renal artery stenosis, coarctation of the aorta, or pheochromocytoma. • The patient has severe chronic heart failure defined by Class III or IV established by the New York Heart Association (NYHA). • The patient has uncontrolled cardiac arrhythmias, MI, PCI, CABG, unstable angina, stroke, or MI within 3 months prior to Visit 1. • By background or according to the disclosure of the 12-electrode physical examination or ECG, the patient suffers from a clinically significant atrioventricular (AV) conduction disorder, for example, second or third degree AV block, sick sinus syndrome or bradycardia clinically significant (resting pulse 2X ULN (depending on the reference ranges of the central laboratory). • The patient has TG> 400 mg / dL (4.52 mmol / L) • The patient has an eGFR 130 mg / dL (3.37 mmol / L) with or without treatment. If receiving treatment, the patient must be receiving a stable dose of an acceptable lipid modifying drug for a minimum of 6 weeks before randomization (Visit 4). • The patient has a BMI> 41 kg / m ^. • The patient is positive for human immunodeficiency virus (HIV) (based on medical history evaluation). • The patient has a history of malignancy <5 years before the end of informed consent, except for basal cell or squamous cell skin cancer or cancer in situ of the cervix properly treated. Melanoma, leukemia, lymphoma and myeloproliferative disorders of any duration are excluded. • Use of other antihypertensive agents such as diuretics, alpha blockers, beta blockers, calcium channel antagonists, direct vasodilators that cannot be discontinued for testing. Note: Patients who are currently on therapy with 3 or more antihypertensives should be excluded. • The patient consumes drugs containing glucocorticoids or androgens daily within 4 weeks prior to Visit 2 (such as spheroids with or without a prescription [OTC], for example, cortisone, hydrocortisone, prednisone, dexamethasone and oral androgen preparations, intramuscular or topical [for example, testosterone, DHEA, DHEA-sulfate]) or have an underlying condition that seems to require these treatments during the study. Note: Patients who are receiving a stable daily dose of inhaled spheroids dur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average of the last 5 measurement was recorded. Measure:Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12 Timepoints:Baseline and Week 12 ; Outcome name:Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average the last 5 measurement was recorded. Measure:Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12 Timepoints:Baseline and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:LDL-C calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration Measure:Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 Timepoints:Baseline and Week 12 ; Outcome name:Fasting weight was assessed at baseline and after 24 weeks of study drug administration and was measured after voiding, with shoes and socks off, wearing clinic gown to reduce variability and maintain consistency. Same standardized digital scale was used throughout the study. Measure:Change From Baseline in Body Weight at Week 24 Timepoints:Baseline and Week 24 ; Outcome name:HbA1c reported as a % and was measured at baseline and after 24 weeks of study drug administration Measure:Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Timepoints:Baseline and Week 24 | — |
Countries
Australia, Chile, Colombia, Denmark, Finland, Malasya, Mexico, Norway, Philippines, Poland, Puerto Rico, Russian Federation, South Africa, Spain, Sweden, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed