PER-055-00已完成未知
A Randomized, Double-Blind Safety and Efficacy Study of Losartan Plus Hydrochlorothiazide Versus Losartan as First-Line Therapy After 6 Weeks in Patients With Severe Hypertension
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2000年10月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- 年龄范围
- 0 至 0（—）
入选标准
- •Severe hypertension, and age exceeds the legal age to give consent.
- •The patient does not take more than 3 antihypertensive medications before entering the study
- •The patient meets the following blood pressure criteria:
- •Patients treated: PADSe minimum mean> 95 mm Hg, PASSe minimum mean <220 mm Hg in the selection; PAD Minimum mean> 110 mmHg PASSe minimum mean <220 mm Hg after the washout period and randomization.
- •Patients not treated: PADSe mean> 110 mm Hg; PASSe mean <220 mm Hg to the selection and to the randomization.
排除标准
- •1. History of secondary hypertension
- •2. History of malignant hypertension, or any evidence of active or impending malignant hypertension, including headache, papilloedema, chest pain.
- •3. History of stroke, transient ischemic attacks, or audible carotid murmurs.
- •4. Documented history of myocardial infarction or angina pectoris.
- •5. History of clinically significant atrioventricular conduction disorders (AV) and does not have a permanent pacemaker.
- •6. History of unexplained syncope within the previous 2 years, or a known syncopal disorder.
- •7. Antecedents of atrial fibrillation.
- •8. History of congestive heart failure or known left ventricular ejection fraction <40%.
- •9. Presence of an obstructive valvular pathology or hemodynamically significant cardiomyopathy.
- •10. Reaction of known prior sensitivity to losartan or HCTZ or to any other drug derived from sulfonamides.
- •11. The patient takes other drugs with hemodynamic effects.
- •12. The patient takes psychotropic medication with possible hemodynamic effects.
- •13. The patient takes lithium.
- •14. Is a regular user of DAINEs (daily) or aspirin at high doses.
- •15. The patient is a concomitant user of ACTH (corticotropin) or oral steroids.
- •16. Patients undergoing hormone replacement therapy (thyroid, testosterone, estrogen) whose regimen was not stable in the last 3 or more months.
- •17. Patient shows evidence of significant liver dysfunction as indicated by clinical history or laboratory evaluation.
- •18. Serum creatinine level> 1.5 mg / dl, and creatinine clearance <60 cm3 / min
- •19. Proteinuria> 2+.
- •20. AST level (SGOT) and / or ALT (SGPT) greater than twice the normal upper level.
- •21. Clinically significant laboratory value outside the established normal range, including without limitation any of the following parameters: hematocrit, hemoglobin or platelet count.
- •22. White blood cell count <3,000 / mm3.
- •23. Serum potassium <3.5 or> 5.5 mEq / L.
- •24. The patient presents hematuria (<20 / hpc) of unknown etiology.
- •25. The patient is HTV or hepatitis B positive, although no screening is required.
- •26. History of clinically important malabsorption, gastrointestinal resection or liver cirrhosis.
- •27. The patient is pregnant or breast-feeding. (NOTE: Women of childbearing age who are not surgically sterilized and use an effective method of contraception or their partner, will only be able to enter the study if they are previously subjected to an exclusionary pregnancy test.
- •28. Fasting serum glucose levels> 240 mg / dl at the baseline.
- •29. The patient has severe concurrent disease that could exclude their participation or survival.
- •30. The patient has a hemorrhagic or platelet disorder.
- •31. The patient currently abuses or has a well-documented history (within the past 2 years) of having abused alcohol or drugs.
- •32. Mental or legal incapacity.
- •33. Participation in another trial with a drug under investigation within 28 days of beginning the baseline period.
- •34. The patient has a single functioning kidney.
- •35. The circumference of the patient´s arm is> 41 cm.
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