None listed
Conditions
Interventions
for a total of 8 weeks.
Introductory Phase: Patients will discontinue their usual antihypertensive drugs and replace them with Valsartan Placebo, PO, QD + Placebo Hydrochlorothiazide, PO, QD + Amlodipine Placebo, PO, QD, for approximately 1 to 2 weeks.
Active treatment phase: This group will be treated with Valsartan 320 mg PO, QD + Hydrochlorothiazide 25 mg, PO, QD + Amlodipine 10 mg, PO, QD for 8 weeks.
Group name:GROUP 4 Type of group
Introductory Phase: Patients will discontinue their usual antihypertensive drugs and replace them with Valsartan Placebo, PO, QD + Placebo Hydrochlorothiazide, PO, QD + Amlodipine Placebo, PO, QD, for approximately 1 to 2 weeks.
Active treatment phase: This group will be treated with Valsartan Placebo PO, QD + Hydrochlorothiazide 25 mg, PO, QD + Amlodipine 10 mg, PO
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of both sexes> 18 years of age and <86 years of age are eligible. 2. Diastolic and systolic blood pressure requirements: a) Diagnosis of moderate to severe hypertension. b) Patients must also comply with blood pressure requirements at visit 2. OR c) MSDBP ≥ 100 mmHg and <120 mmHg, MSSBP ≥ 145 mmHg and <200 mm Hg or MSDBP ≥ 100 mm Hg and <110 mmHg , MSSBP ≥180 mmHg and <200 mmHg after one week of placebo treatment or at any subsequent scheduled study visit or blood pressure assessment during the simple blind introductory period. 3. Written informed consent to participate in the study before performing any of the study procedures. 4. Ability to communicate and to comply with all the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Inability to safely stop all previous antihypertensive medications for a period of 1 to 5 weeks. 2. Patients with MSSBP ≥ 180 mm Hg and MSDBP 40 mlU / ml or 6 weeks after bilateral surgical oophorectomy with or without hysterectomy or who are using one or more of the acceptable methods of contraception. 8. Known moderate or malignant retinopathy. 9. History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack. 10. History of myocardial infarction or all types of revascularization procedures. 11. Heart failure that requires treatment. 12. Second or third degree heart block with or without pacemaker. 13. Angina of any type. 14. Concurrently lethal arrhythmia or symptomatic arrhythmia. 15. Clinically significant valvular heart disease. 16. Evidence of a secondary form of hypertension. 17. Patients with diabetes mellitus type 1 and those patients with diabetes mellitus type 2 that are not well controlled. 18. Any condition that puts the patient at higher risk because of their participation in the study, or that probably prevents the patient from meeting the requirements of the study or completing the study period. 19. Administration of any agent indicated for the treatment of hypertension after the visit 1. 20. Known or probable contraindications to blockers of angiotensin receptors, thiazide diuretics, calcium dihydropyridine antagonists, or drugs with similar chemical structures. 21. Medical or surgical conditions that may significantly alter the absorption, distribution, metabolism or excretion of any drug. 22. Any history of pancreatic injury, pancreatitis or evidence of pancreatic disorder / injury within 1 year of the visit 1. 23. Evidence of liver disease. 24. Evidence of kidney disorder. 25. History of clinically significant allergies including asthma, multiple drug allergies. 26. History of gouty arthritis or autoimmune diseases including systemic lupus erythematosus. 27. Serum sodium and / or serum potassium less than 132 mEq / L and 3.2 mEq / L, respectively, at visit 2. 28. Volume depletion. 29. Current concomitant pharmacological treatment (s) prohibited 30. Any chronic inflammatory condition that requires chronic anti-inflammatory therapy. 31. History of malignancy of any system in the course of the last 5 years. 32. History of drug or alcohol abuse in the course of the last 2 years. 33. History of noncompliance with medical regimens, or lack of willingness on the part of patients to comply with the study protocol. 34. Use of other drugs in research within 30 days of recruitment. 35. Lack of willingness or inability to provide informed conse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Automated blood pressure measurements will be carried out with an Omron blood pressure monitor. The arm with the highest reading of diastolic blood pressure will be used. The patient should be in a relaxed context and measurements should not be taken immediately after making an effort or consuming coffee. After the patient has been sitting for five minutes with the back supported and both feet on the floor, the diastolic and systolic blood pressure will be determined three times. Measure:1) Change with respect to the initial value in MSDBP. 2) Change with respect to the initial value in MSSBP. Timepoints:8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Blood pressure evaluations will be performed to determine if it meets any of the endpoints. The control rates are defined as <140/90 mm Hg for the MSSBP and MSDBP respectively. MAP: Ambulatory monitoring of blood pressure in a subgroup of patients Measure:Secondary Efficacy: 1) Control rate of MSSBP / MSDBP. 2) MSDBP control rate. 3) MSSBP control rate. 4) MSDBP rate of the patients who respond. 5) Rate of MSSBP of the patients who respond. 6) Change from the beginning to the end in the mean ambulatory diastolic blood pressure during 24 hours after dosing (ADBP). 7) Change from the beginning to the end in the mean ambulatory systolic blood pressure during 24 hours after dosing (ASBP). 8) Change from the beginning to the end in the daytime ambulatory diastolic blood pressure (ADBP). 9) Change from the beginning to the end in the mean daytime ambulatory systolic blood pressure (ADBP). 10) Change from the beginning to the end in the average nightly ambulatory diastolic blood pressure (ADBP). 11) Change from the beginning to the end in the mean nighttime ambulatory systolic blood pressure (ADBP). Timepoints:PA measurements: Weeks 5, 7 and 9. MAP: 24 hours after completing the 8-week treatment. ; Outcome name:Automated blood pressure measurements will be carried out with an Omron blood pressure monitor. The arm with the highest reading of diastolic blood pressure will be used. The patient should be in a relaxed context and measurements should not be taken immediately after making an effort or consuming coffee. After the patient has been sitting for five minutes with the back supported and both feet on the floor, the diastolic and systolic blood pressure will be determined three times when standing. Measure:Other efficacy criteria: 1) Diastolic blood pressure in the standing position. 2) Systolic blood pressure in the standing position. Timepoints:Weeks 5, 7 and 9. ; Outcome name:Clinical evaluation of adverse events, | — |
Countries
Greece, Peru, Portugal, Switzerland, United Kindgdom
Outcome results
None listed