None listed
Conditions
Interventions
Combination arm Type of group
Patients will take 4 blind tablets of study medication orally once a day in the morning. The medication should be taken between 6 and 10 in the morning.
Losartan tablets - HCTZ, losartan, and the corresponding placebo will be supplied as coated tablets.
The treatment is oral. The study design includes a basal / washout period and 6 weeks of double-blind therapy.
The subjects will be randomized in a 2: 1 modality to receive either Losartan 50 mg + HCTZ 12.5 mg, or losartan 50 mg.
T
losartan 100 mg to losartan 150 mg
monotherapy arm Type of group
The treatment is oral. The study design includes a basal / washout period and 6 weeks of double-blind therapy.
The subjects will be randomized in a 2: 1 modality to receive either Losartan 50 mg + HCTZ 12.5 mg, or losartan 50 mg.
Then they will return for Visit 4 after 2 weeks of double blind therapy. At this visit, patients who do not respond to therapy (PAD
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: •Severe hypertension, and age exceeds the legal age to give consent. •The patient does not take more than 3 antihypertensive medications before entering the study •The patient meets the following blood pressure criteria: • Patients treated: PADSe minimum mean> 95 mm Hg, PASSe minimum mean 110 mmHg PASSe minimum mean 110 mm Hg; PASSe mean <220 mm Hg to the selection and to the randomization.
Exclusion criteria
Exclusion criteria: 1. History of secondary hypertension 2. History of malignant hypertension, or any evidence of active or impending malignant hypertension, including headache, papilloedema, chest pain. 3. History of stroke, transient ischemic attacks, or audible carotid murmurs. 4. Documented history of myocardial infarction or angina pectoris. 5. History of clinically significant atrioventricular conduction disorders (AV) and does not have a permanent pacemaker. 6. History of unexplained syncope within the previous 2 years, or a known syncopal disorder. 7. Antecedents of atrial fibrillation. 8. History of congestive heart failure or known left ventricular ejection fraction 1.5 mg / dl, and creatinine clearance 2+. 20. AST level (SGOT) and / or ALT (SGPT) greater than twice the normal upper level. 21. Clinically significant laboratory value outside the established normal range, including without limitation any of the following parameters: hematocrit, hemoglobin or platelet count. 22. White blood cell count 5.5 mEq / L. 24. The patient presents hematuria ( 240 mg / dl at the baseline. 29. The patient has severe concurrent disease that could exclude their participation or survival. 30. The patient has a hemorrhagic or platelet disorder. 31. The patient currently abuses or has a well-documented history (within the past 2 years) of having abused alcohol or drugs. 32. Mental or legal incapacity. 33. Participation in another trial with a drug under investigation within 28 days of beginning the baseline period. 34. The patient has a single functioning kidney. 35. The circumference of the patient´s arm is> 41 cm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The measures of effectiveness are constituted by the average of 3 readings of the PASSe and PADSe minimum (by mercury sphygmomanometer) at each visit. The primary response variable that will govern the primary hypothesis is the proportion of patients achieving target blood pressure (average PADSe average 0.5 mg / dl from the baseline). In the baseline and in Week 6 of the double blind phase, or at the time of discontinuation, will be made a physical examination, a routine laboratory evaluation, and an electrocardiogram. Measure:Safety Timepoints:From the baseline to week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Average change in the PADSe in all visits. Measure:Efficacy Timepoints:Week 4 and week 6 ; Outcome name:proportion of patients achieving target blood pressure (average PADSe average <90 mm Hg) at 6 weeks Measure:Efficacy Timepoints:Week 6 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed