Hypertension, diabetes mellitus. MedDRA version: 6.1 Level: SOC Classification code 10007541
Conditions
Interventions
Trade Name: ENALAPRIL MERCK
Pharmaceutical Form: Tablet
INN or Proposed INN: ACE INHIBITORS, PLAIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutic
Sponsors
ISTITUTO AUXOLOGICO ITALIANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria - Men or women of any racial background - Age 40 years and 75 years - SBP 130 mmHg and 140 mmHg or DBP 85 mmHg and 90 mmHg, average of screening and randomisation visits in absence of any antihypertensive medication - FG 100 mg/dl 5.6 mmol/l and 126 mg/dl 7.0 mmol/l between screening and randomisation in absence of any antidiabetic medication - Waist circumference 102 cm in men and 88 cm in women 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: - SBP 140 mmHg or DBP 90 mmHg - Any antihypertensive, antidiabetic or antiobesity medication at the time of or during the 6 months previous to randomisation - Any current or previous cardiovascular or renal disease requiring continuous administration of Ds, Bs, ACEIs, ARBs, CAs, and any other antihypertensive medication - Any medical condition preventing adherence to lifestyle measures included in the protocol - Hepatic disease as AST SGOT or ALT SGPT values equal or greater than two times the upper limit of normal - Chronic renal dysfunction as serum creatinine 2.0 mg/dl - Any gastrointestinal disorder interfering with drug absorption - Known allergy or contraindications to ACEIs or ARBs - Pregnant or lactating women; women in reproductive age not using recognized contraceptive methods - Malignancy within the last 5 years - Clinically significant autoimmune disorders - Drug abuse or alcohol abuse within the last 5 years - History of noncompliance to medical regimens - Incapacity or unwillingness to sign the informed consent - Participation in any investigational clinical trial within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 2.2 Secondary objectivesIn the same group of individuals, the trial will also investigate whether a 65533;the diabetes preventing effects of an ACEI and ARB significantly differ, because of the differ;Primary end point(s): onset of diabetes defined as FG 126 mg/dl or need for antidiabetic therapy or 2 onset of hypertension defined as SBP 140 or DBP 90 mmHg, or need for antihypertensive therapy to a significantly greater extent than addition of a placebo.;Main Objective: 2.1 Primary objectivesIn a group of individuals with high-normal blood pressure SBP 130-139, or DBP 85-89 mmHg , FG in the high but nondiabetic range 100-125 mg/dl , and abdominal obesity abdominal circumference 102 cm in men and 88 cm in women , i.e. with those characteristics of the so called MS that are major predictors of DM and HT, the trial will explore whether addition of an agent blocking the renin-angiotensin system either an ACEI or an ARB over periodically reinforced instructions for suitable lifestyle changes reduces 1 onset of diabetes defined as FG 126 mg/dl or need for antidiabetic therapy or 2 onset of hypertension defined as SBP 140 or DBP 90 mmHg, or need for antihypertensive therapy to a significantly greater extent than addition of a placebo. | — |
Countries
Italy
Outcome results
None listed