EUCTR2007-002422-29-AT进行中（未招募）不适用
An open-label follow-up trial of the efficacy and safety of chronic administration of the combination of telmisartan 40mg + amlodipine 10mg or the combination of telmisartan 80mg + amlodipine 10mg tablets alone or in combination with other antihypertensive medications in patients with hypertension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 687
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
- •1. male or female patients aged at least 18 years at the time of informed consent.
- •2. diagnosis of essential hypertension and blood pressure not adequately controlled before informed consent at enrolment to the preceding trial 1235.6 (EudraCT 2007-002421-68). (Inadequate control defined as seated DBP = 95 mmHg if on existing antihypertensive treatment or seated DBP = 100 mmHg if treatment-naive.)
- •3. failure to respond to 6 weeks treatment with amlodipine 10mg monotherapy in the run-in period of the preceding trial 1235.6 (EudraCT 2007-002421-68). (Failure to respond defined as seated DBP = 90 mmHg.)
- •4. are randomised to the preceding trial 1235.6 (EudraCT 2007-002421-68) and have completed that trial in the 14 days prior to Visit 1.
- •5. willing and able to provide written informed consent (in accordance with Good Clinical Practice and local legislation).
- •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. pregnancy, breast-feeding or women of child-bearing potential who are not practising acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial.
- •2. development of any medical condition in the preceding 1235.6 trial (EudraCT 2007-002421-68) that in the investigator's opinion could be worsened by treatment with either T40/A10 or T80/A10.
- •3. discontinuation from the preceding 1235.6 trial (EudraCT 2007-002421-68) because of any adverse event or any other reason.
- •4. known or suspected secondary hypertension.
- •5. mean seated SBP = 180 mmHg and/or mean seated DBP = 120 mmHg at any visit.
- •6. any clinically significant hepatic impairment.
- •7. severe renal impairment, bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney.
- •8. clinically relevant hyperkalaemia.
- •9. uncorrected volume or sodium depletion.
- •10. primary aldosteronism.
- •11. hereditary fructose or lactose intolerance.
- •12. symptomatic congestive heart failure (New York Heart Academy functional class III-IV).
- •13. patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin receptor blockers (ARBs).
- •14. any new occurrence of drug or alcohol dependency since signing the informed consent form of the preceding 1235.6 trial (EudraCT 2007-002421-68).
- •15. concurrent participation in another clinical trial or any investigational therapy since completion of the preceding 1235.6 trial (EudraCT 2007-002421-68).
- •16. hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
- •17. known allergic hypersensitivity to any component of the formulations under investigation.
- •18. non-compliance with study medication (defined as less than 80% or more than 120%) during the preceding 1235.6 trial( EudraCT 2007-002421-68) .
- •19. administration of ARBs or dihydropyridine calcium channel blockers at any time during the study (apart from trial medication).
- •20. any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan or amlodipine.
研究者
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