Severe hypertension (MSDBP = 110 mmHg and < 120 mmHg).
Conditions
Interventions
Product Name: valsartan
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: valsartan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 160-
Pharmaceutical form o
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, 18 to 80 years of age (inclusive). Female patients must be either post-menopausal for one year or surgically sterile, or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Hormonal contraceptive use is disallowed. 2. Diagnosis of severe hypertension (MSDBP = 110 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Inability to discontinue all prior antihypertensive medications and/or the inability to completely taper off of medications per the manufacturer's recommendations safely for a period of 3 to 28 days as required by the protocol. 2. Refractory hypertension. Defined as patients on two or more antihypertensives and their MSSBP = 180 mmHg and/or MSDBP = 110 mmHg at Visit 1. 3. Known moderate or malignant retinopathy. Defined as: moderate (retinal signs of hemorrhage, microaneurysm, cotton-wool spot, hard exudates, or a combination thereof) or malignant (signs of moderate retinopathy plus swelling of the optic disk). 4. History of hypertensive encephalopathy or cerebrovascular accident any time prior to Visit 1. 5. Transient ischemic attack, myocardial infarction, all types of revascularization procedures at any time prior to Visit 1. 6. Heart failure of any kind. 7. Second or third degree heart block with or without a pacemaker. 8. Angina pectoris of any type. 9. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. 10. Clinically significant valvular heart disease. 11. Evidence of a secondary form of hypertension, including but not limited to any of the following: coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing disease, pheochromocytoma, polycystic kidney disease. 12. Diabetes with poor glucose control as defined by fasting glycosylated hemoglobin (HbA1c) > 7% at Visit 1. 13. Administration of any agent indicated for the treatment of hypertension after Visit 1, with the permitted exception of those anti-hypertensive medications requiring tapering down commencing at Visit 1. 14. Known or suspected contraindications, including a history of allergy to angiotensin receptor blockers or thiazide diuretics. 15. Any surgical or medical conditions 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, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active or active inflammatory bowel syndrome within 12 months prior to Visit 1, currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction regarded as clinically meaningful by the investigator. 16. Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury within 1 year of Visit 1. 17. Evidence of hepatic disease as determined by any one of the following: SGOT (AST) or SGPT (ALT) values > 2 x ULN 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 any one of the following: serum creatinine > 1.5 mg/dL (men) and > 1.3 mg/dL (women), a history of dialysis, or a history of nephrotic syndrome. 19. History of clinically significant allergies including asthma, multiple drug allergies. 20. History of systemic lupus erythematosus. 21. History of gouty arthritis. 22. Serum sodium and/or serum potassium less than 132 mEq/L and 3.2 mEq/L, respectively at Visit 2. 23. Volume depletion. 24. Currently taking concomitant medication(s) listed in Section 6.6.5. 25. Any chronic inflammatory condition needing chronic anti-inflammatory therapy. 26. History of malignancy including leukemia and lymphoma (but not basal skin cancer) w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the blood pressure control (MSSBP/MSDBP < 140/90 mmHg) rates between a once daily regimen of the combination therapy valsartan/HCTZ 160/12.5 mg (with forced titration to 160/25 mg after 14 days and 320/25 mg after 28 days) and the monotherapy of valsartan 160 mg (with forced titration to 320 mg after 14 days) as initial therapy in patients with severe hypertension after 4 weeks of treatment.;Secondary Objective: The secondary objectives of this trial are the following: • percentage of patients achieving systolic and diastolic blood pressure control (MSSBP/MSDBP < 140/90 mmHg) after 6 weeks of treatment • percentage of patients achieving diastolic blood pressure control (MSDBP < 90 mmHg) after 4 and 6 weeks of treatment • percentage of patients achieving systolic blood pressure control (MSSBP < 140 mmHg) after 4 and 6 weeks of treatment • change from baseline in MSSBP and MSDBP after 4 and 6 weeks of the study • safety and tolerability of valsartan/HCTZ 160/12.5 mg as initial therapy in patients with severe hypertension ;Primary end point(s): The primary efficacy variable is the control rate of blood pressure, defined by the mean sitting systolic blood pressure and the mean sitting diastolic blood pressure MSSBP/MSDBP < 140/90 mm Hg. The primary analysis time point is at Week 4 of the study. | — |
Countries
Slovenia, Spain
Outcome results
None listed