None listed
Conditions
Interventions
Patients will take tablets of candesartan 8 mg and placebo matching losartan 50 mg once daily for six weeks. Patients will continue on the same treatment in responders (SiDBP90 mmHg) for an additional six weeks.
Group name:Study group Type of group
Patients will take tablets of losartan 50mg and placebo matching candesartan 8mg once daily for six weeks. Patients will continue on the same treatment in responders (SiDBP90 mmHg) for an additional six weeks.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: - Male and female patients must be at least 21 years of age. - Patients are taking no more than two antihypertensive medications prior to study entrance (Visit 1, Screening Visit). - Blood pressure criteria as defined below: Screening, for entry into placebo period (visit 2, Week -4): 170/90-115 mmHg Eligibility, for entry into active treatment period (Visit 3, Week -2): 170/90-115 mmHg
Exclusion criteria
Exclusion criteria: - Secondary hypertension of any etiology, such as unilateral or bilateral renal disease, renal artery stenosis, coarctation of the aorta or pheochromocytoma. History of malignant hypertension. - History of cerebrovascular accident (stroke) or history of transient ischemic attacks within 1 year. - Documented history of myocardial infarction or angina pectoris within 6 months. - Clinically significant AV conduction disturbance, i.e., second- or third-degree AV block, or left bundle branch block. Sick-sinus syndrome or clinically significant bradycardia (resting heart rate 1.3 mg/dL (115umol/L); males > 1.4 mg/dL (124umoI/L) - Proteinuiia>1+ - AST (SGOT), ALT (SGPT) >50% above normal values - Clinically significant laboratory values outside of the established normal range including but not limited to any of the following parameters: hematocrit, hemoglobin or platelet count. - White Blood Cell count 5.5mmol/L - Hematuria of unknown etiology. Prior to patient entry, any hematuria should be evaluated, the etiology established/documented and treatment rendered as appropriate. - In addition, patients will be excluded if they were known to be HIV or Hepatitis B positive although no screening is required. - Patients will be excluded if they have a history of clinically important malabsorption or gastrointestinal resection or have cirrhosis of the liver. - Pregnant or lactating females. Females of childbearing age who are not surgically sterilized and who are using effective contraception may enter only if an exclusionary pregnancy test is done prior to entering the study. Pregnancy tests will be repeated just prior to randomization, and at Week 6 and 12 of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The proportion of patients who have both a favourable clinical response assessment at the early follow-up visit. Measure:Primary effectiveness criteria Timepoints:7 to 14 days after discontinuation of all antibiotic therapy ; Outcome name:The primary safety variable will be the proportion of patients within each treatment group that experiences one or more drug-related adverse events. Measure:Primary safety criteria Timepoints:Throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The proportion of patients without documented PRSP who have a favourable clinical response assessment at the late follow-up visit. Measure:Secondary clinical effectiveness criteria Timepoints:21 to 28 days after discontinuation of all antibiotic therapy ; Outcome name:The proportion of patients without documented PRSP who have both a favourable clinical and microbiological response assessment at the early and late follow-up visit. Measure:Secondary clinical and microbiological effectiveness criteria Timepoints:7 to 14, 21 to 28 days after discontinuation of all antibiotic therapy ; Outcome name:The proportion of patients with documented PRSP who have both a favourable clinical and microbiological response assessment at the early and late follow-up visit. Measure:Secondary clinical and microbiological effectiveness criteria Timepoints:7 to 14, 21 to 28 days after discontinuation of all antibiotic therapy | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed