EUCTR2008-007711-32-FR进行中（未招募）1 期
A randomised, double-blind, double dummy, active controlled, parallelgroup, forced titration study to compare the fixed-dose combination ofTelmisartan 80mg plus Hydrochlorothiazide 25mg (T80/HCTZ25)versus Telmisartan 80mg (T80) monotherapy as first line therapy inpatients with severe hypertension
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 840
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
- •All of the following inclusion criteria must be met in male and female patients.
- •1. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
- •2. Age 18 years or older
- •3. Patients with severe hypertension as defined SBP =180 mmHg and DBP =95 mmHg at randomisation
- •4. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator’s discretion)
- •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
- •1. Pre-menopausal women (last menstruation =1 year prior to signing informed consent) who:
- •a) are not surgically sterile; or
- •b) are nursing, or
- •c) are pregnant, or
- •d) are of childbearing potential and are NOT practicing acceptable methods of
- •birth control, or do NOT plan to continue practicing an acceptable method
- •throughout the trial.
- •The only acceptable methods of birth control are:
- •Intra-Uterine Device (IUD)
- •Oral contraceptives
- •Implantable or injectable contraceptives
- •Estrogen patch
- •Hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study.
- •2. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
- •3. Known or suspected secondary hypertension (e.g., renal artery stenosis or
- •phaeochromocytoma)
- •4. Mean in-clinic seated cuff SBP =200 mmHg and/or DBP =120 mmHg
- •5. Renal dysfunction as defined by the following laboratory parameters:
- •Serum creatinine >3.0 mg/dL (or >265 umol/L) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.
- •6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal
- •transplant patients or patients with only one kidney
- •7. Clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 mmol/L or >5.5 mmol/L, may be rechecked for suspected error in result)
- •8. Uncorrected sodium or volume depletion
- •9. Primary aldosteronism.
- •10. Hereditary fructose intolerance
- •11. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
- •12. Congestive heart failure NYHA functional class CHF III-IV (Refer to Appendix 10.3)
- •13. Contra-indication to a placebo run-in period (e.g., stroke with-in the past 6 months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past 3 months prior to start of runin period)
- •14. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other
- •clinically relevant cardiac arrhythmias as determined by the Investigator
- •15. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
- •16. Patients whose diabetes has not been stable and controlled for at least the past 3 months as defined by an HbA1C =10%
- •17. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor
- •antagonists
- •18. History of drug or alcohol dependency within 6 months prior to signing the informed consent form
- •19. Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
- •20. Any investigational drug therapy within 1 month of signing the informed consent
- •21. Known hypersensitivity to any component of the trial drugs (telmisartan,
- •hydrochlorothiazide, or placebo)
- •22. History of non-compliance or inability to comply with prescribed medications or protocol procedures (less than 80% or more than 120%, especially during run-in)
- •23. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication
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