MULTICENTRIC, RANDOMIZED, DOUBLE-BLIND STUDY, WITH ACTIVE CONTROL, IN PARALLEL GROUPS, TO EVALUATE THE EFFICACY AND SAFETY OF VALSARTAN 320 MG COMPARED WITH VALSARTAN 160 MG IN HYPERTENSION PATIENTS

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2003年11月24日最近更新: 2023年9月4日

适应症

试验速览

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•1. Women and men between 18 and 80 years of age inclusive.
•2. To those who in the recruitment (visit 2) have been diagnosed with mild to moderate hypertension, with a MSDBP> 95 and <109 mmHg for untreated patients. Patients with previous treatment should have an MSDBP <109 mmHg at visit 1 and an MSDBP> 95 and <109 mmHg at visit 2.
•3. That they have given their written informed consent before any study procedure is performed.
•4. Able to communicate and meet all the requirements of the study.

•1. Severe hypertension (grade 3 of the WHO classification,> 110 mmHg diastolic and / or> 180 mmHg systolic).
•2. Malignant hypertension
•3. Impossibility to discontinue all previous antihypertensive medication safely for a period of 2 weeks, as required by the protocol.
•4. Known background of proteinuria (more than 0.3 grams per day)
•5. Women patients who have not been postmenopausal for a year or who are not surgically sterilized and who are not using an effective contraceptive method, such as barrier methods with spermicides or intrauterine devices. The use of oral contraceptives is not allowed.
•6. Degree m or IV known in the classification of hypertensive retinopathy of Keith-Wagener.
•7. History of hypertensive encephalopathy or stroke at any time before Visit 1.

发起方

OVARTIS BIOSCIENSES PERU S.A.,