Olmesartan + Amlodipine treatment in diabetic patients: evaluating blood pressure control after 48 hours from last administration (missed dose)
- Conditions
- HypertensionMedDRA version: 14.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2010-018774-21-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
WEEK -2 (VISIT 1) •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 or two antihypertensive medications (excluding combinations including test drugs), 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% confirmed before V2) •Able and willing to sign informed consent and to comply with study procedures •Written informed consent prior to enrolment into the study. WEEK 0 (VISIT 2) •Sitting OSBP between 140 and 179 mmHg and sitting ODBP between 90 and 109 mmHg.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
WEEK -2 (VISIT 1) •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 >176,8µmol/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 * These criteria must be checked before visit 2, after having obtained the laboratory results
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to determine whether the Olmesartan 20-40 mg + Amlodipine 5-10 mg combination is at least as effective as the Perindopril 4-8 mg + Amlodipine 5-10 mg combination in reducing office diastolic blood pressure after 24 weeks of treatment, at 48 hours from last administration (missed dose);Secondary Objective: 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;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);Timepoint(s) of evaluation of this end point: At the end of the study
- Secondary Outcome Measures
Name Time Method