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

Conditions: Hypertension
MedDRA version: 12.1Level: LLTClassification code 10015488Term: Essential hypertension

Registration Number: EUCTR2010-018774-21-GR

Lead Sponsor: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

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