Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Covance | INDUSTRY |
| Boryung Pharmaceutical Co., Ltd | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Starting dose of Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea is 60 mg, orally, once a day in the morning.
The planned study duration for each subject is 18 weeks maximum:
The screening period could takes up to 2 weeks (including the 1-week "wash-out" period ) - the screening period duration depends on the prior anti-hypertensive therapy:
Treatment period - 12 weeks. Follow-up period - 4 weeks. The subjects will visit the clinical site every 4 weeks to measure 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. Governing conditions for defining the time of the drug administration is the subject comfort and the time of its visits the research center.
If laboratory tests are scheduled, a patient should come to the research center fasting (food is prohibited for 8 hours before the visit).
All of the clinical evaluations are conducted on the next morning after taking the medication. On the visit day a patient comes to the research center not taking the drug, and after all the planned procedures are conducted the patient is administrated by the drug.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diastolic Blood Pressure (DBP) After 4 Weeks of Treatment | The value of DBP (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 DBP at week 4 minus Value of SBP at baseline). | Baseline and week 4 of treatment |
Not provided
Inclusion Criteria:
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)
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.
9. For women of child-bearing potential: negative urine pregnancy test at Randomization (Day 0)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
Duration of screening period was up to 14 days depended on prior antihypertensive treatment. 184 patients were screened, 179 randomized.
Participants recruitment was conducted in 13 clinical sites of Moscow and Saint-Petersburg between May and October of 2014
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Kanarb (Fimasartan) | 60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period |
| FG001 | Cozaar® (Losartan) | 50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Losartan | Drug | Cozaar® (Losartan), manufactured by MERCK SHARP & DOHME B.V., Netherlands, tablets 50/100 mg |
|
|
| Change in DBP After 8 Weeks of Treatment | The value of DBP (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 DBP at week 8 minus Value of SBP at baseline). | Baseline and week 8 of treatment |
| Change in DBP After 12 Weeks of Treatment | The value of DBP (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 DBP at week 12 minus Value of SBP at baseline). | Baseline and week 12 of treatment |
| Change in SBP After 4 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 4 minus Value of SBP at baseline). | Baseline and week 4 of treatment |
| Change in SBP After 8 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 8 minus Value of SBP at baseline). | Baseline and week 8 of treatment |
| Number of Subjects Who Responded on Therapy | The subject will be considered a responder if SBP (when seated) <140 mmHg or SBP decrease is >10% from baseline. | Week 12 of treatment |
| Moscow Health Department "City Clinical Hospital № 81" | Moscow | Russia |
| State Research Center for Preventive Medicine of Ministry of Health of the Russian gederation | Moscow | Russia |
| St. Petersburg State health agency "City Hospital number 38 it. NA Semashko " | Pushkin | Russia |
| St. Petersburg State healthcare Institution "City Hospital number 28" "Maximilianovskaya" | Saint Petersburg | 190000 | Russia |
| Clinical Hospital n. a. St. Luka | Saint Petersburg | Russia |
| Federal Almazov Medical Research Centre | Saint Petersburg | Russia |
| St. Petersburg State Healthcare Institution 'Diagnostic Centre #85' | Saint Petersburg | Russia |
| St. Petersburg State Institution of Health "City Hospital № 15" | Saint Petersburg | Russia |
| St. Petersburg State Institution of Healthcare "Pokrovskaya City Hospital" | Saint Petersburg | Russia |
| 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 |
| 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 |
| Troitsk City Hospital | Troitsk | Russia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set Population (FAS) - those subjects from Intent-to-treat population (ITT, all randomized patients), who had at least one assessment for efficacy analysis after the start of therapy.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Kanarb (Fimasartan) | 60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period |
| BG001 | Cozaar® (Losartan) | 50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| BMI | Body Mass Index calculated as weight(kg)/height(m^2) | Mean | Full Range | kg/m^2 |
| ||||||||||||||
| Arterial hypertension (AH) duration | The duration of AH in patients at study inclusion in population of all randomized patients | Mean | Full Range | years |
| ||||||||||||||
| Hypertension grade | The grade of blood pressure increase was determined in accordance with Russian guidelines (fourth revision) "Diagnosis and treatment of arterial hypertension". Grade I AH: sistolic blood pressure (SBP) 140-159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg Grade II AH: sistolic blood pressure (SBP) 160-179 mmHg and/or diastolic blood pressure (DBP) 100-109 mmHg | Count of Participants | Participants |
| |||||||||||||||
| Chronic heart failure (CHF) NYHA Class I | Patients with no limitation of physical activity (ordinary physical activity does not cause undue fatigue, palpitation, dyspnea - shortness of breath) but having symptoms of chronic heart failure could be defined as NYHA (New-York Heart Association) Class I of chronic heart failure | Count of Participants | Participants |
| |||||||||||||||
| Prior therapy for arterial hypertension | Count of Participants | Participants |
| ||||||||||||||||
| Smoking history | Count of Participants | Participants |
| ||||||||||||||||
| Alcohol history | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Full Analysis Set Population (FAS) - those subjects from Intent-to-treat population (ITT, all randomized patients), who had at least one assessment for efficacy analysis after the start of therapy. Last observation carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | mm Hg | Baseline and week 12 of treatment |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Diastolic Blood Pressure (DBP) After 4 Weeks of Treatment | The value of DBP (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 DBP at week 4 minus Value of SBP at baseline). | All randomized patients, who had at least one assessment for efficacy analysis after the start of therapy. One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 4. | Posted | Mean | Standard Deviation | mm Hg | Baseline and week 4 of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in DBP After 8 Weeks of Treatment | The value of DBP (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 DBP at week 8 minus Value of SBP at baseline). | All randomized patients, who had at least one assessment for efficacy analysis after the start of therapy. One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 8. | Posted | Mean | Standard Deviation | mm Hg | Baseline and week 8 of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in DBP After 12 Weeks of Treatment | The value of DBP (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 DBP at week 12 minus Value of SBP at baseline). | One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 12 | Posted | Mean | Standard Deviation | mm Hg | Baseline and week 12 of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in SBP After 4 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 4 minus Value of SBP at baseline). | One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 4 | Posted | Mean | Standard Deviation | mm Hg | Baseline and week 4 of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in SBP After 8 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 8 minus Value of SBP at baseline). | One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 8 | Posted | Mean | Standard Deviation | mm Hg | Baseline and week 8 of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Responded on Therapy | The subject will be considered a responder if SBP (when seated) <140 mmHg or SBP decrease is >10% from baseline. | Full Analysis Set Population (FAS) - those subjects from Intent-to-treat population (ITT, all randomized patients), who had at least one assessment for efficacy analysis after the start of therapy. Last observation carried forward (LOCF) imputation method. | Posted | Count of Participants | Participants | Week 12 of treatment |
|
|
18 weeks
The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Kanarb (Fimasartan) | 60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period | 0 | 89 | 0 | 89 | 20 | 89 |
| EG001 | Cozaar® (Losartan) | 50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period | 0 | 90 | 0 | 90 | 15 | 90 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Conjunctival oedema | Eye disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Diarrhoea | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
|
Any study related information could be made public availiable only after Sponsors written permission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boris Berezhanskiy, Medical Advisor | R-Pharm | 0074959567937 | 2468 | berezhanskiy@rpharm.ru |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C558933 | fimasartan |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
Not provided
Not provided
| Male |
|
| Asian |
|
| Grade II |
|
| Has never smoked |
|
| Smoker-in-the-past |
|
| Never-drinking |
|
| Drinking-in-the-past |
|
| Unknown |
|
It was calculated that at least 140 patients (70 patients per group) must be enrolled into the study to achieve 80% power. With regard to 20% of patients withdrawn prematurely or data not suitable for analysis, it was necessary to include at least 176 patients (88 per group) into the study.
|
|
|
|
|
|
|
|
|
|
|
|