.A.

Not Applicable

• Conditions: -I10 Essential (primary) hypertension; Essential (primary) hypertension; I10

• Registration Number: PER-007-98
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1998-09-16
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

-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 <45 beats/minute).
-History of unexplained syncope within the prior 2 years, or a known syncopal disorder.
-Atrial flutter or atrial fibrillation or an accessory bypass tract (e.g., Stokes-Adams syndrome or Wolff-Parkinson-White syndrome).
-History of congestive heart failure or a known left ventricular ejection fraction <40%.
-Presence of hemodynamically significant obstructive valvular disease or cardiomyopathy.
-Percutaneous coronary angioplasty or coronary artery bypass surgery within the prior 6 months.
-Prior known sensitivity reaction to angiotensin n antagonists (e.g. losartan, candesartan, valsartan, irbesarlan, eprosartan) or hydrochlorothiazide. Patients with a history of angioedema are excluded from the study.
-Except as explicitly stated in the protocol, concomitant use of an agent that could cause a lowering of blood pressure is not permitted during the study (e.g., B-blockers [excluding ophthalmic preparations], diuretics, angiotensin-converting enzyme inhibitors, nitrates, calcium channel blockers).
-Patients taking major psychotropic agents such as phenothiazines, or chronic doses of antidepressants (used to treat depression) are not allowed. Lithium is not allowed.
-Regular use of NSAIDs or high-dose aspirin is not permitted, however, aspirin taken prophylactically as a cardioprotective agent al 100 mg/day is permitted. Acetaminophen is the preferred agent for pain relief.
-Concomitant use of oral steroids or ACTH is not allowed. Replacement hormones (thyroid, testosterone, estrogen) are permitted. Oral contraceptives are allowed unless the patient´s hypertension was induced by this medication.
-Serum Creatinine: females > 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 <3000/mm^.
-Serum potassium <3.5 or >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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified