A randomized, double blind, parallel group, active-controlled, multi-center, 14 week study to evaluate the effectiveness of a valsartan versus an amlodipine treatment strategy in achieving blood pressure control in patients with stage 1 or stage 2 hypertension or uncontrolled on present monotherapy
- Conditions
- Essential hypertension
- Registration Number
- EUCTR2005-000684-26-FI
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1244
1. Male or female outpatients, age between 18- 75 years of age, inclusive, at Visit 1
2. Stage/grade 1 or stage/grade 2 hypertension, MSSBP = 140 mm Hg, and/or MSDBP = 90 mm Hg, (based on the JNC-VII/ESC/ESH guidelines), at Visit 1 and 2 in untreated patients Untreated is defined as treatment naïve or patients not treated in the past 12 weeks.
Or
Patients who are currently treated on monotherapy and uncontrolled (i.e. MSSBP =
140 mm Hg, and/or MSDBP = 90) and have a blood pressure = 160/100 mmHg at Visit 1 and Visit 2. Treatment is defined as having taken medication for a minimum of 4 weeks and until = 2 days prior to Visit 1.
Patients who neither meet the definition of treated or untreated will not be eligible for study entry.
3. Written informed consent to participate in the study prior to any study procedures
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. Current treatment with a CCB
2. MSSBP = 180 mm Hg or MSDBP = 110 mm Hg at any time between Visit 1 and Visit 2
3. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
4. Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, renal artery stenosis, or pheochromocytoma, etc.
5. Cerebrovascular accident or myocardial infarction during the last 12 months, prior to Visit 1
6. Transient ischemic cerebral attack during the last 6 months, prior to Visit 1
7. History of/or symptoms consistent with congestive heart failure
8. Clinically significant valvular heart disease
9. Second or third degree heart block without a pacemaker
10. Concomitant angina pectoris
11. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia
12. Diabetes mellitus
13. Serum potassium < 3.5 or > 5.5 mmol/L without medication at Visit 1
14. Serum creatinine > 1.5 ULN at Visit 1 or a history of dialysis or nephrotic syndrome
15. ALT or AST values > 2 x ULN at Visit 1 or a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
16. 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) at Visit 1
17. 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 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods: surgical sterilization (e.g., bilateral tubal ligation, hysterectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap).
18. Any surgical or medical condition which might alter the absorption, distribution,
metabolism, or excretion of any drug
19. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
20. History of any severe or life- threatening disease
21. History of drug or alcohol abuse within the last two years
22. History of noncompliance to medical regimens, or patients unwilling to comply with the study protocol
23. Any condition in the investigators opinion, which renders the patient unable to complete the study or which would produce significant risk to the patient
24. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer
25. Persons directly involved with the conduct of this study
26. Inability to communicate and comply with all study requirements
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