PER-051-06已完成未知
RANDOMIZED, DOUBLE-BLIND, DOUBLE SIMULATION, PLACEBO CONTROLLED, FACTORIAL DESIGN 3X4 STUDY, TO EVALUATE TELMISARTAN TABLETS 20 AND 80 MG IN COMBINATION WITH RAMIPRIL CAPSULES 1.25; 10; AND 20 MG AFTER EIGHT WEEKS OF TREATMENT IN PATIENTS WITH HYPERTENSION STAGES I AND II, WITH A MAP SUBSTUDY, FINAL VERSION 26 SEPTEMBER 2005
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Ability to provide written informed consent in accordance with GCP and local legislation
- •2. Hypertension defined by an average diastolic blood pressure taken in a sitting position, with cuff, ≥95 mmHg and ≤ 119 mmHg at Visit 3.
- •3. 18 years of age (or older according to state or provincial local policies).
- •4. Ability to suspend any current antihypertensive treatment without unacceptable risk to the patient.
排除标准
- •1. Pre-menopausal women who: a) are not surgically sterile; or b) are breastfeeding, or c) are pregnant, or d) have reproductive potential and are NOT using acceptable methods of birth control, or DO NOT plan to continue with an acceptable method throughout the study.
- •2. Night workers who routinely sleep during the day and whose work at night includes the period between midnight and 4:00 a.m.
- •3. Known or suspected secondary hypertension.
- •4. DBP ≥ 120 mmHg and / or SBP ≥ 180 mmHg average taken in the clinic, in a sitting position, with a cuff or during any previous visit to the randomization.
- •5. Hepatic and / or renal dysfunction defined by the following laboratory parameters: a. SGPT (ALT) or SGOT (AST)> 2 times the upper limit of the normal range, or b. Serum creatinine> 3.0 mg / dL (or> 265 pmol / 1).
- •6. Bilateral stenosis of the renal artery, stenosis of the renal artery in a single kidney, patients with a kidney transplant or patients with only one kidney
- •7. Clinically relevant hypokalemia or hyperkalemia.
- •8. Uncorrected sodium or volume depletion.
- •9. Primary aldosteronism.
- •10. Hereditary fructose intolerance.
- •11. Obstructive biliary disorders or liver failure.
- •12. Congestive heart failure, functional class of NYHA III or IV.
- •13. Contraindication for an introductory placebo period.
- •14. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other clinically relevant cardiac arrhythmia.
- •15. Obstructive hypertrophic cardiomyopathy, 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 previous 3 months.
- •17. Patients who have previously experienced characteristic symptoms of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists
- •18. History of dependence on drugs or alcohol within the previous six months.
- •19. Concomitant administration of any medication with known effect on blood pressure.
- •20. Any experimental pharmacotherapy within a month of signing the informed consent form.
- •21. Known hypersensitivity to any component of the study drugs.
- •22. History of non-compliance or inability to comply with prescribed medications or protocol procedures.
- •23. Any clinical condition that would not allow a safe completion of the protocol and a safe administration of the study medications.
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