PER-032-01已完成未知
DOUBLE BLIND, RANDOM, TWO ARM, PARALLEL STUDY WITH LOSARTAN OR ATENOLOL FOR THE EVALUATION OF THE HEALTH OF PATIENTS WITH MILD TO MODERATE HYPERTENSIO
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2001年6月28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
- •The patient has recently been diagnosed with mild to moderate hypertension (PADSe> 90 mmHg <109 mmHg) before starting therapy with the placebo of the basal drug (Visit 1).
- •The patient has a PADSe> 90 mmHg <109 mmHg before starting active treatment at Visit 2.
- •The patient´s age is> 40 and <49 years.
- •The patient is a married man who maintains a stable heterosexual relationship, has no history of sexual dysfunction and has been satisfied with his sexual life in general.
- •The patient´s spouse normally stays close to the patient (does not take long trips or take long vacations) during the study.
- •The patient has had sexual intercourse at least 2 times, but not more than 10, during a period of two weeks before Visit 1.
- •The patient can go to the doctor in the morning for each of the scheduled visits and complete the health assessment questionnaire that each individual completes.
排除标准
- •The Patient´s PASSe is> 180 mmHg at Visit 1, 2 or on any subsequent visit, the patient should be discontinued.
- •Patient PADSe is not properly controlled (PADSe> 110 mmHg) during active treatment, the patient should be discontinued from the study.
- •Secondary hypertension of any etiology, for example, unilateral or bilateral nephropathy, stenosis of the renal artery, stenosis of the isthmus of the aorta or pheochromocytoma.
- •Malignant hypertension.
- •History of cerebrovascular disease or transient ischemic attacks within the last six months.
- •Patients with a history of myocardial infarction within the last six months.
- •The patient suffers from chest pain of any etiology.
- •The patient suffers from coronary heart disease.
- •The patient presents arrhythmias or clinically significant conduction disturbances.
- •Arylends of undefined syncope or presence of a known disease associated with syncope (eg, Adams-Stokes disease).
- •History or presence of heart failure or a left ventricular ejection fraction of <40%.
- •Hemodynamically significant obstructive valve disease or hypertrophic cardiomyopathy.
- •Percutaneous coronary angioplasty or bypass surgery of the coronary within the last six months. Patients with a less recent operation or PTCA may be included if they are in a stable condition with respect to health and medication.
- •Clinically significant peripheral vascular disease, which could pose a risk to the patient during therapy with a beta-blocker.
- •Any lung disease that represents a contraindication to atenolol, such as asthma.
- •Neurological diseases that at the discretion of the researcher would damage sexual function.
- •Has a history or currently manifests abuse of alcohol or drugs.
- •The patient underwent surgery of the penis, prostate or pelvis due to erectile dysfunction or some invasive urological procedure.
- •Patients with penile implants or assistive devices (inflatable balloons, rigid prostheses).
- •The concurrent and continuous use of agents that could affect blood pressure (the use of beta-blockers is allowed for ophthalmological preparations).
- •The concurrent use of substances with an important psychotropic action, for example, phenothiazine or chronic antidepressants.
- •Treatment with the H2 receptor antagonist, cimetidine, (the use of famotidine and ranitidine is accepted).
- •Regular use of NSAIDs. The use of aspirin in low doses (<325 mg / day) for cardiac protection is accepted.
- •Concomitant treatment with steroids, ACTH, lithium or any drug that may impair sexual function.
- •Treatment with a drug known to affect sexual function, such as diuretics for edema, or alternative therapies, such as medicines / remedies based on yohimbine and herbs.
- •Patients have some evidence of significant renal or hepatic dysfunction according to their medical history or a laboratory test that has recently been performed.
- •Any evidence of significant deviations in laboratory values from the normal range, including, without limitations, hematocrit, hemoglobin, platelet count, and white blood cell count.
- •Serum potassium <3.5 or> 5.5 mval / 1 (mEq / 1).
- •Some hematuria of unknown etiology.
- •History or presence of clinically significant malabsorption syndrome or gastrointestinal resection.
- •History of chronic liver disease.
- •Patient with diabetes.
- •Other severe concomitant diseases tha
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