MULTICENTER, DOUBLE-BLIND, DRUG-CONTROLLED, PARALLEL GROUPS STUDY TO COMPARE THE COMBINATION OF VALSARTAN 320 MG PLUS HYDROCHLOROTHIAZIDE 12.5 MG AND VALSARTAN 320 MG PLUS HYDROCHLOROTHIAZAZIDE 25 MG WITH VALSARTAN 320 MG IN PATIENTS WITH MILD TO MODERATE HYPERTENSION NOT CONTROLLED ADEQUATELY WITH VALSARTAN 320 MG.
- Conditions
- -I10 Essential (primary) hypertensionEssential (primary) hypertensionI10
- Registration Number
- PER-071-04
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Ambulatory patients of both sexes from 18 to 80 years of age inclusive
• With diagnosis in Visit 2 of mild to moderate hypertension with a PADMS> 95 and <110 mmHg for untreated patients. Patients treated previously should have a PADMS <110 mmHg at Visit 1 and a PADMS> 95 and <110 mmHg at Visit 2.
• At Visit 3 all patients should have a PADMS> 90 mmHg and <110 mmHg.
• Written informed consent to participate in the study before performing any study procedure
• Ability to communicate and meet all the requirements of the study
• Severe hypertension (PADMS> 110 mmHg and / or PASMS> 180 mmHg).
• Impossibility to safely discontinue all previous antihypertensive medications for a period of 2-4 weeks, as required by the protocol.
• Women who have not been postmenopausal for a year or hysterectomized, or who do not use contraceptive methods recognized as the barrier method with spermicide or an intrauterine device. The use of hormonal contraceptives is not allowed.
• History of hypertensive encephalopathy or cerebrovascular accident during the year preceding the visit 1.
• Knowledge of Keith-Wagener hypertensive retinopathy grade III or IV.
• Attack of transient cerebral ischemia, myocardial infarction, all types of revascularization procedures during the last 12 months before Visit 1.
• Heart failure that requires treatment.
• Second or third degree heart block without a pacemaker.
• Concomitant refractory angina.
• Arrhythmia with potential life risk or concurrent symptomatic arrhythmia
• Clinically significant valvular heart disease.
• Evidence of a secondary form of hypertension, such as coarctation of the aorta, hypoaldosteronism, unilateral or bilateral stenosis of the renal arteries, Cushing´s disease, pheochromocytoma, polycystic nephropathy, etc.
• Diabetic patients who require insulin treatment
• Patients with type 2 diabetes who, in the opinion of the researcher, are not adequately controlled.
• Administration of any agent indicated for the treatment of hypertension after Visit 1, with the exception of antihypertensive drugs that require gradual dose reduction from Visit 1.
• Knowledge or suspicion of contraindications, including a history of allergy to angiotensin antagonists or hydrochlorothiazide, or other drugs derived from sulfonamides.
• Serum sodium value <132 mmol / L in Visit 1.
• Serum potassium values <3.5 mmol / L or> 5.5 mmol / L in Visit 1.
• Any surgical or medical condition that could 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 band surgery, inflammatory bowel syndrome currently active or active within the 12 months prior to Visit 1, gastritis, ulcers or gastrointestinal / rectal bleeding currently active, or obstructions of the urinary tract considered clinically significant by the investigator.
• Pancreatic lesion, pancreatitis or evidence of deterioration of pancreatic function / injury within the 12 months prior to Visit 1.
• Evidence of liver disease determined by any of the following: SGOT or SGPT values> 2 x LSN at Visit 1, history of hepatic encephalopathy, history of esophageal varices, or antecedent portocava shunt.
• Evidence of renal failure determined by any of the following: serum creatinine> 1.5 LSN at Visit 1, history of dialysis or history of nephrotic syndrome.
• History of malignancy including leukemia and lymphoma (but not skin cancer a
• basal cells) within the last five years
• Pregnant or lactating women.
• Any condition - not identified in the protocol - that in the opinion of the investigator or the Novartis medical monitor would jeopardize the efficacy or safety evaluation.
• Any surgical or medical condition that, in the opinion of the investigator,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The PADMS is defined as the average of the available readings of the diastolic blood pressure in the sitting position of a visit.<br>Measure:Change from baseline in mean diastolic blood pressure in sitting position (PADMS) valley at the end point<br>Timepoints:Week 16<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Change from the baseline value in diastolic blood pressure in standing and sitting positions on visits 4 and 5<br>Measure:Change from the baseline value in diastolic blood pressure in standing and sitting positions on visits 4 and 5<br>Timepoints:Visits 4 and 5<br>;<br>Outcome name:Change from baseline in systolic blood pressure in standing and sitting position on visits 4 and 5<br>Measure:Change from baseline in systolic blood pressure in standing and sitting position on visits 4 and 5<br>Timepoints:Visits 4 and 5<br>