OLMESARTAN +AMLOIPINE TREATMENT IN DIABETIC PATIENTS: EVALUATING BLOOD PRESSURE CONTROL AFTER 48 HOURS FROM THE LAST ADMINISTRATION (MISSED DOSE)

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 260

Inclusion Criteria

- Outpatients aged 40-70 years
- Male and female gender (females of childbearing potential must be using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner)
- Females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test
- Patients with essential hypertension never treated or taking one antihypertensive medication, but not-normalised (mean sitting OSBP between 140 and 179 mmHg and mean sitting ODBP between 90 and 109 mmHg)
- Type II diabetes mellitus controlled by diet or oral hypoglycaemic drug treatment (HbA1c<7.5%)
? Able and willing to sign informed consent and to comply with study procedures
? Written informed consent prior to enrolment into the study.
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

- Malignant or secondary hypertension
- Isolated systolic hypertension (sitting OSBP<140 mmHg and ODBP <90 mmHg)
- Orthostatic hypotension (difference between mean sitting and standing SBP>20 mmHg)
- Myocardial infarction or unstable angina at the time of enrolment
- Cerebrovascular events in the previous 3 months
- Heart failure requiring medical treatment
- Body mass index >35 kg/m2
- Any clinically relevant haematological or biochemical abnormality on routine screening, according to Investigator's judgment
- Liver pathology (AST or ALT >3 times greater than normal upper limit or total serum bilirubin >1.5 times greater than normal upper limit)*
- Renal insufficiency (creatininemia >200 µmol/L or 2 mg/dL)*
- Severe concurrent pathology, including terminal illness (cancer, AIDS, etc.)
- Insulin treatment
- Dementia, psychosis, alcoholism (>350 g ethanol/week) or chronic abuse of medicines, drugs or psychoactive substances
- Cardiogenic or septic shock
- Haemodynamically significant valvulopathy
- Hereditary/idiopathic angioedema
- History of angioedema associated with previous ACE-inhibitor therapy
- Bilateral renal arterial stenosis, or unilateral for patients with a single kidney
- Hypokalemia (<3.5 mEq/L) or hyperkalemia (>5.0 mEq/L) shown in at least two haematological examinations (if the patient presents at baseline with hypo or hyperkalemia, this value must be re-tested during run-in period). Before inclusion in the study the patient must have a normal potassium value.*
- Females who are pregnant or lactating
- Hypersensitivity or contraindications to treatment with AT1-antagonists, ACE-inhibitors or calcium-antagonists
- History of undesired side effects with AT1-antagonists, ACE-inhibitors or calcium-antagonists
- Introduction of concurrent therapies among those not permitted and which cannot be suspended without harm to the patient
- Concurrent or recent (<1 month) participation in other clinical trials
- Conditions which in the Investigator's opinion may interfere with the study's execution or due to which the patient should not participate for safety reasons
- Risk of low patient cooperation
- Inability or unwillingness to issue the informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Secondary objectives will be the assessment of efficacy on office systolic blood pressure and pulse pressure, on central blood pressure and on the radial artery-derived haemodynamic indices, as well as the assessment of safety;Main Objective: To demonstrate that 24 weeks of treatment with Olmesartan + Amlodipine combination is at least as effective as the Perindopril + Amlodipine combination in reducing sitting office diastolic blood pressure measured at the brachial artery level 48 hours after last administration, in essential hypertensive patients with diabetes mellitus.;Primary end point(s): Office (brachial) sitting diastolic blood pressure change after 24 weeks of treatment at 48 hours from last administration (missed dose) (Visit 6b - baseline)

Secondary Outcome Measures

Name	Time	Method

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