Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, de control activo, de 14 semanas de duración para evaluar la efectividad de la estrategia de tratamiento de valsartan con respecto a amlodipino para alcanzar un control de la presión arterial en pacientes con hipertensión grado l o grado 2 o no controlada actualmente en monoterapia.

ovartis Farmacéutica S.A0 sites0 target enrollmentStarted: January 20, 2006Last updated: September 7, 2021

Conditions

Trial Snapshot

Phase: Phase 1
Status: Active, not recruiting
Sponsor

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

Inclusion Criteria

•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.
•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

Exclusion Criteria

•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

Investigators

Sponsor

ovartis Farmacéutica S.A

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