Essential hypertension with associated Diabetes Mellitus type 2.
Conditions
Interventions
Trade Name: TEVETENS
Product Name: Tevetens
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Eprosartan mesylate
CAS Number: 0144143-96-4
Concentration unit: mg milligram(s)
Concentration
Sponsors
SOLVAY PHARMACEUTICALS GMBH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 40 to 80 years of age (inclusive). A female of child-bearing potential may be enrolled provided that she: - is routinely using adequate hormonal contraception, either in a depot or oral formulation at a stable dose for at least three months prior to the start of the treatment or a barrier method (intrauterine device, diaphragm, combination of condom and spermicide) prior to and during the trial and - is not breast feeding and - agrees not to attempt to become pregnant during the trial. A female of non-childbearing potential may be enrolled in the study, and will be defined as one who has been postmenopausal for at least 24 months, has been surgically sterilized (i.e. tubal ligation) or had a hysterectomy prior to the screening phase. 2. Eligible patients should have diagnosed essential hypertension (not controlled with current treatment, i.e., BP = 130/80 - = 179/109 mmHg) and diagnosed associated diabetes mellitus type 2, willing to accept withdrawal of any antihypertensive medication by the time of the Screening visit. 3. Patients have given and signed informed consent by visit V0. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Grade 3 hypertension (systolic BP = 180 mmHg and/or diastolic BP = 110 mmHg). 2. Symptoms of orthostatic hypotension or supine systolic BP = 90 mmHg. 3. Secondary forms of hypertension including, but not limited to, coarctation of aorta, primary aldosteronism, pheochromocytoma, or due to current use of hormonal contraceptive agents. 4. Any form of rhythm or conduction abnormality requiring therapy. 5. Clinically significant heart failure (NYHA class III and IV) or in need of treatment with ACE inhibitors or diuretics. 6. Signs, symptoms, or history of myocardial infarction or cerebrovascular accident during the past three months. 7. Any form of angina pectoris requiring therapy. 8. Severe obstructive airway disease with permanent respiratory insufficiency. 9. Diabetic mellitus type 1 and subjects with HbA1c > 8.5%. 10. Creatinine > 2 x upper normal limit. 11. SGOT or SGPT > 2 x upper normal limit. 12. Presence of any condition which limits life expectancy (cancer, haematological diseases, etc.). 13. Problems with compliance or follow-up anticipated. 14. Participation in another trial or study within the past 30 days. 15. Pregnancy and lactation. 16. Known hypersensitivity to ingredients of Eprosartan, Ramipril, Hydrochlorothiazide or Moxonidine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of combination therapy of Eprosartan/HCTZ (600/12.5 mg) versus Ramipril/HCTZ (5/12.5 mg) in terms of proportion of patients brought to goal blood pressure (< 130/80 mmHg) at V3 vs. V2 (after four weeks of treatment).;Secondary Objective: To compare the: 1.Efficacy of combination therapy Eprosartan/HCTZ/Moxonidine vs Ramipril/HCTZ/Moxonidine in terms of proportion of patients non-responders to the double combination, brought to goal blood pressure at V5 vs. V3 2.-5.Mean change in sitting systolic blood pressure (sitSBP) and sitting diastolic blood pressure (sitDBP) between the different therapy alternatives (monotherapy-non-responders, double- and triple-combination therapy) 6.Parameters of glycemic control as well as fasting lipid profile parameters between the triple-combination therapy arms (V5 vs. V2) 7. To demonstrate that there are no additional safety concerns that may outweigh the additional benefit of the double and triple combination treatment as compared to the monotherapy with Eprosartan 600 mg respectively to Ramipril 5 mg. ;Primary end point(s): The percentage of patients who after four weeks of double-combination therapy have reached blood pressure goal: BP < 130/80 mmHg in the two arms compared. | — |
Countries
Italy, Spain
Outcome results
None listed