Hypertension MedDRA version: M15 Level: LLT Classification code 10020772
Conditions
Interventions
Trade Name: Diovan 80 mg kapszula
Product Name: Diovan 80 mg kapszula
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Valsartan
Current Sponsor code: VAL489
Concentration unit: mg milligram(s)
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients. 2. Patients aged 18 to 80 years (inclusive). 3. Patients with mild and moderate hypertension defined by a MSSBP >=140 mmHg and 135 mmHg in daytime BP of ABPM. If the patient refuses ABPM resting supine SBP has to be > 140 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Inability to discontinue ARB´s safely for a period of 1 week, as required by the protocol. 2. Treatment with more than 3 different compounds for the treatment of hypertension at visit 1. 3. Atrial fibrillation. 4. Malignant hypertension. 5. Known Keith-Wagener grade III or IV hypertensive retinopathy. 6. History of hypertensive encephalopathy or cerebrovascular accident within the preceding 12 months. 7. Known or suspected contraindications including history of allergy to angiotensin II receptor blockers as described in the basic product information (see SPC). 8. Previous unsuccessful use of Angiotensin Receptor Blocker. 9. Heart failure NYHA III-IV. 10. Second or third degree heart block without pacemaker. 11.Concomitant refractory angina pectoris. 12. Concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia. 13. Clinically significant valvular heart disease. 14. Transient ischemic cerebral attack, stroke or myocardial infarction during the last 12 months prior to Visit 1. 15. Diabetes mellitus with poor glucose control as defined by HbA1c > 8,5% at Visit 1. 16. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug including but not limited to any of the following: - History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection. - Currently active, or active inflammatory bowel syndrome within 12 months prior to Visit 1. - Currently active gastritis, ulcers or gastrointestinal/ rectal bleeding. - Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/ injury. - Evidence of hepatic disease or cholestasis as determined by any one of the following: ALT or AST values 2 x ULN at visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of a portocaval shunt. - History of biliary cirrhosis or obstruction of bile duct. - Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator. 17. History of malignancy of any organ system, treated or untreated, within the past five years, whether or not evidence of local recurrence or metastasis exists, are excluded, with the exception of localized basal cell carcinoma of the skin. 18. History of any severe, life-threatening disease. 19. History of drug or alcohol abuse within the last 2 years. 20. History of non-compliance to medical regimens, or those patients unwilling to comply with the trial protocol. 21. Participation in any investigational drug trial within one month prior to Visit 1. 22. Any condition, which in the judgment of the investigator or medical monitor, would jeopardize the evaluation of efficacy or safety. 23. Any surgical or medical conditions 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 it. 24. Unwillingness or inability to give informed consent. 25. Persons directly involved in the execution of this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy variable is predialytic MSSBP after 4 weeks treatment with valsartan 80 mg and irbesartan 150 mg. ;Secondary Objective: 1. Changes in electronically measured predialytic, MSDBP and pulse pressure. 2. Occurrence of hypotension (SBP < 100 mmHg) with or without symptoms during treatment (questionnaire) and during dialysis. 3. Safety and tolerability (adverse events and laboratory abnormalities). 4. 24 hour mean ambulatory BP and pulse pressure (calculated by averaging the patient’s available hourly means). 5. Mean nighttime and daytime ambulatory BP (calculated by averaging the patient’s available hourly means for nighttime and for daytime). 6. Changes in quality of life. 7. Changes in hs-CRP-, catecholamine, aldosterone and angiotensin II levels. ;Primary end point(s): Primary end point: The primary efficacy variable is predialytic MSSBP after 4 weeks treatment with valsartan 80 mg and irbesartan 150 mg. Secondary end points: Changes in electronically measured predialytic, MSDBP and pulse pressure. Occurrence of hypotension (SBP < 100 mmHg) with or without symptoms during treatment (questionnaire) and during dialysis. Safety and tolerability (adverse events and laboratory abnormalities). 24 hour mean ambulatory BP and pulse pressure (calculated by averaging the patient’s available hourly means). Mean nighttime and daytime ambulatory BP (calculated by averaging the patient’s available hourly means for nighttime and for daytime). Changes in quality of life. Changes in hs-CRP-, catecholamine, aldosterone and angiotensin II levels. | — |
Countries
Hungary
Outcome results
None listed