PER-078-04已完成未知
A Study to Evaluate the Safety and Efficacy of Valsartan/Amlodipine Compared to Lisinopril/Hydrochlorothiazide Given Once Daily for 6 Weeks is Patients With Severe Hypertension
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2004年12月10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
入选标准
- •Outpatient patients> 18 years old male or female. Female patients must be in the post-menopausal stage for one year or sterile by surgical methods or must be using an effective method of contraception as a barrier method with spermicide or an intra-uterine device. The use of hormonal contraceptives is not allowed.
- •Patients with severe hypertension should have been measured by a standard calibrated aneroid or a mercury sphygmomanometer. Patients should have a MSDBP> 95 mmHg and <120 mmHg at Visit 2 and MSDBO> 110 mmHg and <120 mmHg at Visit 3.
排除标准
- •Inability to completely discontinue all previous anti-hypertensive medications in a safe manner for a period of 3 weeks required by the protocol
- •Knowledge of Keith-Wagener grade III or IV hypertensive retinopathy.
- •History of hypertensive encephalopathy or cerebrovascular accident at any time before Visit 1.
- •Transient ischemic attack, myocardial infarction, all types of revascularization procedures at any time before Visit 1.
- •Heart failure of any kind.
- •Second or third degree heart block with or without pacemaker
- •Any type of angina.
- •Potentially life-threatening coextensive arrhythmia or symptomatic arrhythmia
- •Clinically significant cardiac vascular disease.
- •Evidence of a secondary form of hypertension, including but not limited to any of the following: coarctation of the aorta, hyperaldosteronism, stenosis of the unilateral or bilateral renal artery, Cushing´s disease, pheochromocytoma, poikic renal disease.
- •Diabetic patients who require treatment with insulin.
- •Type 2 diabetics with poor glucose control defined by fasting glycosylated hemoglobin {Hb1Ac)> 7% at Visit 2.
- •Administration of any agent indicated for the treatment of hypertension with a minimum of 3 days before Inclusion within the continuous phase of single-blind study (Visit 2), with the permitted exception of that antihypertensive medication that requires to be reduced begun in Visit 1.
- •Knowledge or suspicion of contraindications, including history of allergy to angiotensin receptor blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors or thiazide diuretics.
- •Any medical or surgical condition that can significantly alter the absorption, distribution, metabolism or excretion of any drug including but not limited to any of the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, bypass Gastric stapling, gastric stapling or gastric anchoring, isitis 1, current active gastritis, ulcer or gastrointestinal / rectal bleeding, or obstruction of the urinary tract considered as clinically significant for the researcher.
- •Any history of pancreatic damage, pancreatitis or evidence of pancreatic insufficiency function / damage within 1 year of the visit 1.
- •Evidence of liver disease determined by any of the following tests: SGOT (AST) or SGPT (ALT) values> 2 x ULN at visit 1, a history of hepatic encephalopathy, a history of esophageal varices or a history of portocaval shunt.
- •Evidence of renal failure determined by any of the following: serum creatinine> 1.5 mg / dL (men) and> 1.3 mg / dL (women), a history of dialysis, or a history of nephrotic syndrome.
- •History of malignancy including leukemia and lymphoma (but not cancer of basal skin cells) within the past 5 years.
研究者
相似试验
已完成
Unknown
study on overall improvement of Skin ParametersCTRI/2023/06/054242Transformative Learning Solutions Pvt Ltd75
进行中（未招募）
1 期
A Study to Evaluate the Safety and efficacy of the Antibody APX005M in Adult Patients with Metastatic Melanoma Who have not Received Prior Immunotherapynresectable or metastatic melanomaMedDRA version: 20.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 100000004864EUCTR2018-003864-30-ESApexigen, Inc.36
尚未招募
不适用
Safety and Efficacy assessment of Product on skiCTRI/2022/06/043478Sun Pharmaceutical Industries Limited
进行中（未招募）
不适用
A study to determine the safety and efficacy of a terbinafine topical formulation system in subjects with onychomycosis in laser treated toenails versus ciclopirox lacquer in intact toenailsDistal/lateral Subungual onychomycosis (DSO) caused by dermatophytesMedDRA version: 8.1Level: LLTClassification code 10030338Term: OnychomycosisEUCTR2006-005895-42-ISTLT Medical Ltd.235
进行中（未招募）
1 期
A Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody APX005M Administered in Combination with Nivolumab in Subjects with Non-small Cell Lung Cancer and Subjects with Metastatic Melanomaon-small Cell Lung Cancer and Metastatic MelanomaMedDRA version: 20.0 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 100000004864EUCTR2018-003866-14-ESApexigen, Inc.174