Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan) and Cozaar® (Losartan) in Adult Patients With Grade I-II Arterial Hypertension

PHASE3CompletedINTERVENTIONAL
Enrollment

179

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Arterial Hypertension
Interventions
DRUG

Fimasartan

"Starting dose of Kanarb (Fimasartan) is 60 mg, orally, once a day in the morning. The subjects will visit the clinical site every 4 weeks to measure Arterial blood pressure (ABP). The dose will be doubled in case if SBP ≥140 mmHg or DBP ≥90 mmHg at Visit 3 (Day 28) or at Visit 4 (Day 56).~If necessary, the dose of the study drug may be increased based on the assessment of patient's condition performed at the phone contact (Day14±3). Patient may be called for an unscheduled visit for treatment adjustment (decided individually, with possibility of dose titration as per investigator's judgment, indicated in source documents).~When possibilities are, the patient should be administrated by the study medication at the same time in the morning."

DRUG

Losartan

Cozaar® (Losartan), manufactured by MERCK SHARP \& DOHME B.V., Netherlands, tablets 50/100 mg

Trial Locations (13)

190000

"St. Petersburg State healthcare Institution City Hospital number 28 Maximilianovskaya", Saint Petersburg

Unknown

"Federal State Institution Russian Cardiology Research and Production Complex of the Ministry of Health and Social Development of the Russian Federation (FSI Cardiology Russian Healthcare Ministry)", Moscow

"Moscow Health Department City Clinical Hospital № 81", Moscow

State Research Center for Preventive Medicine of Ministry of Health of the Russian gederation, Moscow

"St. Petersburg State health agency City Hospital number 38 it. NA Semashko ", Pushkin

Clinical Hospital n. a. St. Luka, Saint Petersburg

Federal Almazov Medical Research Centre, Saint Petersburg

St. Petersburg State Healthcare Institution 'Diagnostic Centre #85', Saint Petersburg

"St. Petersburg State Institution of Health City Hospital № 15", Saint Petersburg

"St. Petersburg State Institution of Healthcare Pokrovskaya City Hospital", Saint Petersburg

"State Budget Education Institution of Higher Professional Education North-Western State Medical University named after I.I. Mechnikov on base St. Petersburg State Institution of Healthcare Pokrovskaya City Hospital", Saint Petersburg

"State Budget Education Institution of Higher Professional Education North-Western State Medical University named after I.I. Mechnikov, the department faculty and hospital care, court number 5", Saint Petersburg

Troitsk City Hospital, Troitsk

Sponsors
All Listed Sponsors
collaborator

Covance

INDUSTRY

collaborator

Boryung Pharmaceutical Co., Ltd

INDUSTRY

lead

R-Pharm

INDUSTRY

NCT02248961 - Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan) and Cozaar® (Losartan) in Adult Patients With Grade I-II Arterial Hypertension | Biotech Hunter | Biotech Hunter