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

NCT02248961 | Completed Phase 3 Results

• 1 other identifier: CC09042014
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 13

Brief Summary

Assess and compare the efficacy and safety of Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan), manufactured by MERCK SHARP \& DOHME B.V., Netherlands, tablet 50/100 mg in adult patients with Grade I-II arterial hypertension in 12 weeks of therapy

Conditions

Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure (SBP) After 12 Weeks of Treatment

  The value of SBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest. "Change" was calculated as (Value of SBP at week 12 minus Value of SBP at baseline).

  Baseline and week 12 of treatment

Secondary Outcomes (6)

• Change in Diastolic Blood Pressure (DBP) After 4 Weeks of Treatment

  Baseline and week 4 of treatment

• Change in DBP After 8 Weeks of Treatment

  Baseline and week 8 of treatment

• Change in DBP After 12 Weeks of Treatment

  Baseline and week 12 of treatment

• Change in SBP After 4 Weeks of Treatment

  Baseline and week 4 of treatment

• Change in SBP After 8 Weeks of Treatment

  Baseline and week 8 of treatment

Study Arms (2)

Kanarb (Fimasartan)

EXPERIMENTAL

88 subjects will receive Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg for 12 weeks

Drug: Fimasartan

Cozaar® (Losartan)

ACTIVE COMPARATOR

88 subjects will receive Cozaar® (Losartan), manufactured by MERCK SHARP \& DOHME B.V., Netherlands, tablets 50/100 mg for 12 weeks

Drug: Losartan

Interventions

Fimasartan DRUG

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.

Also known as: Kanarb

Kanarb (Fimasartan)

Losartan DRUG

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

Also known as: Cozaar®

Cozaar® (Losartan)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of both sex aged 18-75 inclusively.
• Subjects who signed their written Informed Consent for participation in the study and willing to adhere to all Protocol procedures.
• Subjects with documented diagnosis of grade I-II primary arterial hypertension within at least 3 months before screening.
• Systolic blood pressure (SBP) (when seated) at Screening (Day -14)
• For subjects administered with anti-hypertensive therapy: SBP ≤ 179 Hg
• For subjects receiving no anti-hypertensive therapy (so called 'naïve' patients): 140≥SBP ≤179.
• As per investigator's judgment, subjects with controlled arterial hypertension must benefit from the therapy switch to Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan), manufactured by MERCK SHARP \& DOHME B.V., Netherlands, .
• For subjects administered with anti-hypertensive drugs: the anti-hypertensive drug may be safely cancelled during the "wash-out" period according to the investigator's judgment.
• For women of child-bearing potential: negative urine pregnancy test at screening (Day -14). 8. Systolic blood pressure (SBP) (when seated) at Randomization (Day 0) ≥140 mmHg and ≤179 mmHg.
• \. For women of child-bearing potential: negative urine pregnancy test at Randomization (Day 0)

You may not qualify if:

• Grade III Arterial Hypertension.
• Arterial hypotension (SPB ≤100 mm Hg) at Screening (Day -14) and/or Randomization (Day 0).
• Subjects needing treatment with more than one anti-hypertensive drug (more than one active substance, including complex drugs).
• Secondary (symptomatic) arterial hypertension.
• Known bilateral renal arterial stenosis or unilateral renal arterial stenosis.
• Hyperpotassemia \>5,0 mmol/l (as per blood biochemistry results at Screening).
• Primary hyperaldosteronism.
• Known hypersensitivity to angiotensin-II receptors antagonists or any other study drug or comparator component.
• Contraindications for use of angiotensin-II receptors antagonists.
• Myocardial infarction and or unstable angina, and/or acute cerebrovascular accident/transient ischemic attack, and/or percutaneous coronary intervention, and/or coronary arterial bypass graft, acute coronary arteries involvement, and/or obliterative vascular atherosclerosis of low extremities, and/or grade III and IV retinopathy in anamnesis.
• Clinically significant cardiac valves damage.
• Cardiomyopathies
• Chronic Heart failure (CHF) (except for CHF FC I NYHA).
• Creatinine clearance less than 60 ml/min/1.73m2 calculated by Cockroft-Gault formula.
• Known moderate to severe hepatic insufficiency and/or transaminase increase: AST and/or ALT ≥2\*ULN.

Sponsors & Collaborators

• R-Pharm: lead
• Covance: collaborator
• Boryung Pharmaceutical Co., Ltd: collaborator

Study Sites (13)

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, Russia

Location

Moscow Health Department "City Clinical Hospital № 81"

Moscow, Russia

Location

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

Moscow, Russia

Location

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

Pushkin, Russia

Location

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

Saint Petersburg, 190000, Russia

Location

Clinical Hospital n. a. St. Luka

Saint Petersburg, Russia

Location

Federal Almazov Medical Research Centre

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

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, Russia

Location

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, Russia

Location

Troitsk City Hospital

Troitsk, Russia

Location

MeSH Terms

Conditions

Hypertension

Interventions

fimasartan; Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Results Point of Contact

• Title: Boris Berezhanskiy, Medical Advisor
• Organization: R-Pharm

berezhanskiy@rpharm.ru

0074959567937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 25, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 6, 2019
• Results First Posted: May 6, 2019

Record last verified: 2019-02

Locations

RU (13)