MULTICENTRIC, RANDOMIZED, DOUBLE-BLIND STUDY, IN PARALLEL GROUPS, WITH ACTIVE CONTROL, OF 24 WEEKS OF DURATION, TO EVALUATE THE EFFICACY OF THE COMBINATION VALSARTAN / HYDROCHLOROTHYAZIDE VERSUS AMLODIPINE ON THE SYSTOLIC ARTERIAL PRESSURE IN PATIENTS WITH MODERATE HYPERTENSION WITH RISK FACTORS AND / OR CARDIOVASCULAR CONCOMYANT DISEASE

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2003年2月25日最近更新: 2023年9月4日

适应症

试验速览

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•Male patients or women> 18 years of age with moderate hypertension defined by an MSSBP of> 160 mmHg and a pulse pressure> 70 mmHg in Visits 1, 2 and 3 for untreated patients. Patients currently treated with antihypertensives, who continue uncontrolled (ie, MSSBP> 140 mmHg) with treatment and who have a blood pressure of <160/95 mmHg at Visit 1 and a proven clinical history of moderate hypertension. Patients previously treated should meet the MSSBP criteria> 160 mmHg and a pulse pressure> 70 mmHg at Visit 3.

•1. MSSBP> 190 mmHg and / or MSDBP> 110 mmHg at any time from Visit 1 to Visit 3.
•2. Impossibility to discontinue all previous antihypertensive medication safely during a period of three weeks.
•3. Mandatory indication of any concomitant medication that is not allowed in the study.
•4. Women patients who have not been post-menopausal 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 or dermal implants as the only method of contraception is not allowed.
•5. Keith-Wagener grade III or IV known hypertensive retinopathy.
•6. History of hypertensive encephalopathy or stroke less than 1 year before Visit 1.

发起方

OVARTIS BIOSCIENSES PERU S.A.,