EUCTR2010-018774-21-IT进行中（未招募）不适用
Olmesartan + Amlodipine treatment in diabetic patients: evaluating blood pressure control after 48 hours from last administration (missed dose) - OLMAM
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
进行中（未招募）
不适用
OLMESARTAN +AMLOIPINE TREATMENT IN DIABETIC PATIENTS: EVALUATING BLOOD PRESSURE CONTROL AFTER 48 HOURS FROM THE LAST ADMINISTRATION (MISSED DOSE)HypertensionEUCTR2010-018774-21-DEMENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA240
进行中（未招募）
不适用
OLMESARTAN +AMLOIPINE TREATMENT IN DIABETIC PATIENTS: EVALUATING BLOOD PRESSURE CONTROL AFTER 48 HOURS FROM THE LAST ADMINISTRATION (MISSED DOSE)MedDRA version: 12.1Level: LLTClassification code 10015488Term: Essential hypertensionHypertensionEUCTR2010-018774-21-GRMENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA240
进行中（未招募）
1 期
OLMESARTAN +AMLOIPINE TREATMENT IN DIABETIC PATIENTS: EVALUATING BLOOD PRESSURE CONTROL AFTER 48 HOURS FROM THE LAST ADMINISTRATION (MISSED DOSE)MedDRA version: 12.1 Level: LLT Classification code 10015488 Term: Essential hypertensionHypertensionEUCTR2010-018774-21-FRMENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA260
进行中（未招募）
不适用
Randomised Olmesartan and Diabetes Microalbuminuria Prevention Study - RoadmapIDDM (no insulin dependent diabetes mellitus)Classification code 10029402EUCTR2004-000506-52-LVSankyo Pharma GmbH4,400
进行中（未招募）
不适用
Randomised Olmesartan and Diabetes Microalbuminuria Prevention Study - ROADMAPIDDM (non insulin dependent diabetes mellitus)MedDRA version: 8.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusEUCTR2004-000506-52-GBDaiichi Sankyo Europe GmbH4,400