None listed
Conditions
Interventions
Group 1 Type of group
100 mg of losartan / 25 mg of HCTZ and a placebo to compare 10 mg of amlodipine plus placebo to compare 25 mg of HCTZ for 12 weeks.
Group name:Group 2 Type of group
10 mg of amlodipine plus 25 mg of HCTZ and placebo to compare 100 mg of losartan / 25 mg of HCTZ for 12 weeks.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient has a history of moderate-severe hypertension (SiDBP> 100 mmHg). • The patient has a diastolic blood pressure in the sitting position of> 90 mmHg in the selection (Visit 1). • The patient is taking two or more monotherapy agents in Visit 1, as documented in the patient´s medical history. • The patient has a diastolic blood pressure in the valley sitting position of> 90 mmHg at Visit 2 and has suspended the antihypertensive medication on the morning of the day before Visit 2. • The patient has a diastolic blood pressure in valley sitting position of> 90 mmHg at Visit 3. • The patient has at least one symptom of the questionnaire that is related to open-label therapy and which, in the opinion of the researcher, can be improved after a change to 100 mg of losartan blindly plus 25 mg of HCTZ or 10 mg of amlodipine blindly plus 25 mg of HCTZ. • The patient is between 18 and 75 years old.
Exclusion criteria
Exclusion criteria: 1. The patient has a history of serious adverse experiences related to the use of beta adrenergic blocking agents (P blockers), diuretic, angiotensin II antagonist (AIIA) or calcium channel blockers (CCBs). 2. The patient has a concurrent disease (s) that causes a treatment that could directly or indirectly affect the patient´s blood pressure. 3. The patient is a pregnant or lactating woman or a potentially fertile woman, who does not use effective contraceptive methods. 4. The patient has secondary hypertension of any etiology such as unilateral or bilateral stenosis of the renal artery, coarctation of the aorta, stenosis of the aortic isthmus, pheochromocytoma or primary aldosteronism. 5. The patient has a history of malignant hypertension. 6. The patient has a systolic blood pressure in the sitting position> 220 mmHg. 7. The patient has a history of congestive heart failure, stroke, myocardial ischemia, transient ischemic attack or hypertensive encephalopathy. 8. The patient has a history of myocardial infarction in the previous year. 9. The patient showed cardiac rhythm abnormalities such as clinically relevant VA conduction abnormalities, for example, 2 and 3 degree VA block, left bundle branch block. 10. The patient has sick sinus syndrome or clinically relevant bradycardia (resting heart rate 1 g / day). Low-dose aspirin ( 75 mg / dl; 12.5 mmol / 1 or BUN> 35 mg / dL Serum creatinine> 1.7 mg / 100 ml; 150 umol / 1 Proteinuria +2 in test strip (rod) SGOT> 50% above the normal range SGPT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurements of blood pressure in sitting position and valley foot with conventional sphygmomanometry and evaluation of symptoms will be carried out with a validated questionnaire. Measure:Efficacy (Blood Pressure) Timepoints:Until week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Evaluation of adverse experiences, conventional laboratory tests and electrocardiogram (ECG) measurements Measure:Proportion of patients with any adverse experience Timepoints:During all of the study ; Outcome name:Measurements of blood pressure in sitting position and valley foot with conventional sphygmomanometry will be carried out. The goal is defined as SiDBP <90 mmHg in Week 12 Measure:Proportion of patients reaching the target SiDBP in Week 12 Timepoints:Week 12 ; Outcome name:Measurements of blood pressure in sitting position and valley foot with conventional sphygmomanometry will be carried out. Measure:The change from the baseline (Visit 3) through Week 12 in the SiDBP valley. Timepoints:Week 12 ; Outcome name:Measurements of blood pressure in sitting position and valley foot with conventional sphygmomanometry will be carried out. The goal is defined as SiDBP <90 mmHg in Week 12 or a reduction of at least 10 mmHg in Week 12 Measure:Proportion of patients reaching the target SiDBP in Week 12 Timepoints:Week 12 ; Outcome name:The SiSBP, StDBP and StSBP at a specific time point are defined as the average of 3 consecutive measurements of SiSBP, StDBP and StSBP, respectively. The pulse pressure is defined as the difference between SiSBP and SiDBP. Measure:The change from the baseline to Week 12 in the systolic blood pressure in the sitting position (SiDBP), in the systolic and diastolic blood pressure of the foot (StSBP and StDBP) and in the pulse pressure. Timepoints:Week 12 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed