EUCTR2010-018774-21-FR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)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
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
入选标准
- •- 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
排除标准
- •- 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
研究者
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