Hipertensión en paciente con hipertensión y diabetes Hypertension in Patients with Hypertension and Diabetes MedDRA version: 9.1 Level: LLT Classification code 10020772 Term: Hypertension
Conditions
Interventions
Product Name: MK-0736
Product Code: MK-0736
Pharmaceutical Form: Tablet
Current Sponsor code: MK 0736
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceu
Sponsors
Merk & Co., Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is ≥18 years of age and ≤75 years of age. 2) Patient has Type II diabetes (T2DM) and: HbA1c ≥ 7.0% and ≤ 9.0 %. Is not newly diagnosed (within 3 months of Visit 1) Is not taking new or recently adjusted anti-diabetic pharmacotherapy (with the exception of ±10 units of insulin) within 3 months of Visit 1. 3) A patient who is of reproductive potential agrees to remain abstinent* or use (or have their partner use) 2 acceptable methods of birth control for the duration of the study. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, condom, vasectomy, and hormonal contraception. 4) At Randomization, SiSBP ≥120 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patient has a history of type 1 diabetes mellitus or history of ketoacidosis. 2) Patient has decompensated valvular disease, presence of hemodynamically significant obstructive valvular disease or cardiomyopathy. 3) Patient has a history of malignancy ≤ 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. 4) Patient is human immunodeficiency virus (HIV) positive (as assessed by medical history). 5) Patient has received treatment with any investigational drugs within the past 30 days. 6) Patient does not agree to comply with restrictions on alcohol (average allowed intake of < 14 drinks per week and no alcohol intake within 24 hours prior to all clinic visits requiring fasting laboratory analysis) or patient has a history of alcohol or drug abuse within the past 3 years. 7) Patient has BMI ≥ 41 kg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of MK-0736 compared to placebo at Week 12 on trough sitting diastolic blood pressure (SiDBP) and trough sitting systolic blood pressure (SiSBP).;Secondary Objective: 1) To assess the effect of MK-0736 on LDL-C at Week 12. 2) To assess the effect of MK-0736 on body weight at Week 24. 3) To assess the effect of MK-0736 on HbA1c at Week 24. 4) To assess the safety and tolerability MK-0736 at Week 24 . 5) To assess the effect of MK-0736 on adrenal androgens at Week 24. 6) To assess the safety and tolerability of treatment with MK-0736 at Week 76. 7) To assess the effect of MK-0736 on adrenal androgens at Week 76.;Primary end point(s): Mean trough SiSBP and SiDBP | — |
Countries
Denmark, Finland, Spain, Sweden
Outcome results
None listed