A double-blind, randomized, multicenter 8 weeks study to evaluate the efficacy and safety of of valsartan / amlodipine combination based therapy versus amlodipine monotherapy based therapy in patients with stage II hypertension - ND
- Conditions
- Stage II hypertensionMedDRA version: 8.1Level: PTClassification code 10015488Term: Essential hypertension
- Registration Number
- EUCTR2006-000850-33-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 636
1 Male or female patients / 18 years of age 2 Patients must meet the following criteria prior to randomization Stage II hypertension with MSSBP / 160 mm Hg and MSSBP / 200 mm Hg at Visit 2 3 Patients must have signed and received a copy of the informed consent prior to study enrollment or any study related activities
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Known or suspected contraindications, including history of allergy to ARBs, CCB, thiazides or to drugs with similar chemical structure 2. MSSBP 200 mmHg and/or MSDBP 120 mmHg at any time between Visit 1 and Visit 2. 3. Patients on previous antihypertensive medication who are controlled MSSBP 140 mmHg at screening visit. 4. Uncontrolled patients with more than two medication at screening visit 5. History of hypertensive encephalopathy, cerebrovascular accident. 6. History of myocardial infarction or unstable angina within 1 years prior to Visit 1 Novartis Confidential Page 12 Clinical Study Protocol Study No. CVAA489A2403 7. History of transient ischemic attack 8. Malignant hypertension 9. Evidence of a secondary form of hypertension, to include coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, or pheochromocytoma 10. Known Keith-Wagener grade III or IV hypertensive retinopathy 11. Percutaneous coronary intervention PCI or coronary artery bypass graft surgery CABG within 1 years prior to Visit 1 12. Diabetes mellitus type 1 13. History of heart failure Grade II - IV according to the NYHA classification 14. Second or third degree heart block without a pacemaker 15. Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia 16. Clinically significant valvular heart disease 17. Evidence of hepatic disease as determined by one of the following ALT or AST values 3 x UNL at visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt 18. Evidence of renal impairment as determined by one of the followings serum creatinine 1.5 x UNL at visit 1, a history of dialysis, or a history of nephrotic syndrome 19. Serum sodium value 135 mmol/L at visit 1 20. Serum potassium values 3.5 mmol/L or 5.5 mmol/L at visit 1 21. Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug 22. Women of child-bearing potential WOCBP , defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal 12 months of natural spontaneous amenorrhea or 6 weeks post surgical bilateral oophorectomy and/or hysterectomy OR are using one or more of the following acceptable methods of contraception surgical sterilization e.g., bilateral tubal ligation, hysterectomy , hormonal contraception implantable, patch, oral , and double barrier methods1 any double combination of IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap 23. Pregnant or nursing lactating women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test 5 mIU/ml 24. Any surgical or medical condition which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period Novartis Confidential Page 13 Clinical Study Protocol Study No. CVAA489A2403 25. History of malignancy of any organ system within the past five years, treated or untreated, includin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method