跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/PER-068-06
PER-068-06已完成未知

MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY, WITH PARALLEL GROUPS AND 8 WEEKS OF DURATION, TO EVALUATE THE EFFICACY AND SAFETY OF THE VALSARTAN / HCTZ / AMLODIPINE COMBINATION COMPARED WITH VALSARTAN / HCTZ, VALSARTAN / AMLODIPINE AND HCTZ / AMLODIPINE IN PATIENTS WITH MODERATE TO SEVERE HYPERTENSIO

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2006年10月18日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

试验速览

阶段
未知
状态
已完成
发起方
研究概览入排标准研究者记录与标识符相似试验

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

  • •1. Patients of both sexes> 18 years of age and <86 years of age are eligible.
  • •2. Diastolic and systolic blood pressure requirements: a) Diagnosis of moderate to severe hypertension. b) Patients must also comply with blood pressure requirements at visit 2. OR c) MSDBP ≥ 100 mmHg and <120 mmHg, MSSBP ≥ 145 mmHg and <200 mm Hg or MSDBP ≥ 100 mm Hg and <110 mmHg , MSSBP ≥180 mmHg and <200 mmHg after one week of placebo treatment or at any subsequent scheduled study visit or blood pressure assessment during the simple blind introductory period.
  • •3. Written informed consent to participate in the study before performing any of the study procedures.
  • •4. Ability to communicate and to comply with all the requirements of the study.

排除标准

  • •1. Inability to safely stop all previous antihypertensive medications for a period of 1 to 5 weeks.
  • •2. Patients with MSSBP ≥ 180 mm Hg and MSDBP <100 mm Hg should be withdrawn from the study at any time between one week (7 ± 3 days) and four weeks of placebo treatment.
  • •3. Patients treated with two or more antihypertensive drugs with MSSBP ≥ 180 mm Hg and / or MSDBP ≥ 110 mm Hg at visit 1.
  • •4. Patients treated with three or more antihypertensive agents with MSDBP ≥ 90 mm Hg and <110 mm Hg and MSSBP ≥ 140 mmHg and <180 mm Hg at visit 1.
  • •5. Patients treated with four or more antihypertensive drugs at visit 1.
  • •6. Pregnant or lactating women.
  • •7. Women of potential fertile age UNLESS they meet the following definition of a postmenopausal woman: 12 months of natural amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels> 40 mlU / ml or 6 weeks after bilateral surgical oophorectomy with or without hysterectomy or who are using one or more of the acceptable methods of contraception.
  • •8. Known moderate or malignant retinopathy.
  • •9. History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack.
  • •10. History of myocardial infarction or all types of revascularization procedures.
  • •11. Heart failure that requires treatment.
  • •12. Second or third degree heart block with or without pacemaker.
  • •13. Angina of any type.
  • •14. Concurrently lethal arrhythmia or symptomatic arrhythmia.
  • •15. Clinically significant valvular heart disease.
  • •16. Evidence of a secondary form of hypertension.
  • •17. Patients with diabetes mellitus type 1 and those patients with diabetes mellitus type 2 that are not well controlled.
  • •18. Any condition that puts the patient at higher risk because of their participation in the study, or that probably prevents the patient from meeting the requirements of the study or completing the study period.
  • •19. Administration of any agent indicated for the treatment of hypertension after the visit 1.
  • •20. Known or probable contraindications to blockers of angiotensin receptors, thiazide diuretics, calcium dihydropyridine antagonists, or drugs with similar chemical structures.
  • •21. Medical or surgical conditions that may significantly alter the absorption, distribution, metabolism or excretion of any drug.
  • •22. Any history of pancreatic injury, pancreatitis or evidence of pancreatic disorder / injury within 1 year of the visit 1.
  • •23. Evidence of liver disease.
  • •24. Evidence of kidney disorder.
  • •25. History of clinically significant allergies including asthma, multiple drug allergies.
  • •26. History of gouty arthritis or autoimmune diseases including systemic lupus erythematosus.
  • •27. Serum sodium and / or serum potassium less than 132 mEq / L and 3.2 mEq / L, respectively, at visit 2.
  • •28. Volume depletion.
  • •29. Current concomitant pharmacological treatment (s) prohibited
  • •30. Any chronic inflammatory condition that requires chronic anti-inflammatory therapy.
  • •31. History of malignancy of any system in the course of the last 5 years.
  • •32. History of drug or alcohol abuse in the course of the last 2 years.
  • •33. History of noncompliance with medical regimens, or lack of willingness on the part of patients to comply with the study protocol.
  • •34. Use of other drugs in research within 30 days of recruitment.
  • •35. Lack of willingness or inability to provide informed conse

研究者

发起方
OVARTIS BIOSCIENSES PERU S.A.,

相似试验

已完成
1 期
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-I10 Essential (primary) hypertensionEssential (primary) hypertensionI10
PER-060-03OVARTIS BIOSCIENSES PERU S.A.,
已完成
不适用
Study In People With Type 2 Diabetes
PER-061-05GLAXOSMITHKLINE PERU S.A.,
已完成
不适用
Dose-Ranging Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
PER-028-04OVARTIS BIOSCIENSES PERU S.A.,
已完成
不适用
TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES WITH AN INVESTIGATIONAL NEW DRUG
PER-084-02GLAXOSMITHKLINE RESEARCH TRIANGLE PARK,
进行中（未招募）
不适用
RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY OF THE EFFICACY, TOLERABILITY AND SAFETY OF VALDECOXIB (BEXTRA®)10 MG OD VS. DICLOFENAC SODIUM 50 MG TDS FOR 6 WEEKS IN SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE. - N/AOsteoarthritis of the kneeClassification code 10031161
EUCTR2004-001713-34-GBPfizer Limited516