Arterial HypertensionPhase 3NCT02248961
Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan) and Cozaar® (Losartan) in Adult Patients With Grade I-II Arterial Hypertension
A Phase 3 study testing Fimasartan and Losartan in people with Arterial Hypertension, run by R-Pharm at 13 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arterial Hypertension
- What is being tested?
- Fimasartan and Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 13 sitesRussia
- Study dates
- May 2014to Aug 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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).
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- 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.
- History of infections (HIV, hepatitis B or C, syphilis).
- Uncontrolled Diabetes mellitus, Glycosylated hemoglobin level (HbA1c) >7%.
- Severe systemic diseases, such as gastro-intestinal tract diseases, autoimmune disorders, blood disorders and other conditions which may affect on the study drugs' absorption, distribution and and excretion.
- Clinically significant abnormalities of laboratory parameters.
- Drug or alcohol addiction, psychiatric disorders.
- Medical history of oncological disease within 5 years before screening.
- Subjects with biliary tracts obstruction.
- Subjects with genetic disorders, such as galactose intolerance, congenital lactase insufficiency and glucose-galaclose malabsorption syndrome.
- Any other acute disease or progression and/or decompensation at the moment of enrollment
- Necessity to administer or administration of prohibited concomitant drugs from the "List of Prohibited Drugs" within 14 days before enrollment
- Pregnancy or breast-feeding period; fertile women not using adequate contraception methods
- Participation in another clinical trial within 3 months before Screening.
- Other medical or psychiatric conditions or lab abnormalities that may increase potential risk associated with study participation and IP administration, or that may affect study results interpretation and as per investigator's judgment, make the subject ineligible.
- Study site personnel or Sponsor's representatives immediately involved in the study.
- Subjects, excluded from the study may not be included in it again.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Russia13 sites
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
St. Petersburg State healthcare Institution "City Hospital number 28" "Maximilianovskaya"
Saint Petersburg, 190000
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
About this study
Official title: Open-label, Randomized, Multicenter, Efficacy and Safety Evaluating Study to Compare 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
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
Read the detailed description
- To evaluate efficacy of 12-week 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.
- To evaluate safety of 12-week 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.
- Assess the pharmacokinetics parameters of Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea in adult patients with arterial hypertension I-II stage after a single dose.
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:
- "naive" subjects who never received therapy (which must be reflected in the source documents), may be randomized after completion of all screening procedures;
- Subjects receiving anti-hypertensive therapy which may be discontinued without prior dose reduction must undergo a 7 days "wash-out" period, so the screening period will take at least 7 days;
- Subjects, receiving anti-hypertensive therapy which requires dose reduction before discontinuation must undergo the 7 days "wash-out" period after the last dose administration, so the screening period will consist of dose reduction period and a "wash-out" period.
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.
- Conditions
- Arterial Hypertension
- Being tested
- Fimasartan, Losartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FimasartanDrug
Also called Kanarb
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.
LosartanDrug
Also called Cozaar®
Cozaar® (Losartan), manufactured by MERCK SHARP \& DOHME B.V., Netherlands, tablets 50/100 mg
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and week 12 of treatment
Secondary outcomes (6)
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).
Measured: Baseline and week 4 of treatment
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Week 12 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance, Boryung Pharmaceutical Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248961
- Sponsor's protocol ID
- CC09042014
- Status last verified
- Feb 2019
- First submitted
- 22 Sep 2014
- Last updated
- 6 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, Multicenter, Efficacy and Safety Evaluating Study to Compare 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
- ClinicalTrials.gov ID
- NCT02248961
- Acronym / sponsor ID
- CC09042014
- Conditions
- Arterial Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Collaborators
- Covance, Boryung Pharmaceutical Co., Ltd
- Study start
- May 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Posted 6 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- To evaluate efficacy of 12-week 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.
- To evaluate safety of 12-week 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.
- Assess the pharmacokinetics parameters of Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea in adult patients with arterial hypertension I-II stage after a single dose.
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:
- "naive" subjects who never received therapy (which must be reflected in the source documents), may be randomized after completion of all screening procedures;
- Subjects receiving anti-hypertensive therapy which may be discontinued without prior dose reduction must undergo a 7 days "wash-out" period, so the screening period will take at least 7 days;
- Subjects, receiving anti-hypertensive therapy which requires dose reduction before discontinuation must undergo the 7 days "wash-out" period after the last dose administration, so the screening period will consist of dose reduction period and a "wash-out" period.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kanarb (Fimasartan) | Experimental | Drug: Fimasartan88 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 | Drug: Losartan88 subjects will receive Cozaar® (Losartan), manufactured by MERCK SHARP \& DOHME B.V., Netherlands, tablets 50/100 mg for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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, .
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FimasartanAlso: KanarbStarting 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 | Kanarb (Fimasartan) |
| LosartanAlso: Cozaar®Cozaar® (Losartan), manufactured by MERCK SHARP \& DOHME B.V., Netherlands, tablets 50/100 mg | Drug | Cozaar® (Losartan) |
Primary outcome
Change in Systolic Blood Pressure (SBP) After 12 Weeks of Treatment
Time frame: Baseline and week 12 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).
6 secondary outcomes
Change in Diastolic Blood Pressure (DBP) After 4 Weeks of Treatment
Time frame: Baseline and week 4 of treatment
Change in DBP After 8 Weeks of Treatment
Time frame: Baseline and week 8 of treatment
Change in DBP After 12 Weeks of Treatment
Time frame: Baseline and week 12 of treatment
Change in SBP After 4 Weeks of Treatment
Time frame: Baseline and week 4 of treatment
Change in SBP After 8 Weeks of Treatment
Time frame: Baseline and week 8 of treatment
Number of Subjects Who Responded on Therapy
Time frame: Week 12 of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fimasartan and Losartan in people with Arterial Hypertension, run by R-Pharm at 13 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure (SBP) After 12 Weeks of Treatment (time frame: Baseline and week 12 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.