Stroke, Not Specified as Hemorrhage or InfarctionPhase 4NCT02758912
Clinical Study of Medicinal Product Cardionat® Using in Health Athlete Volunteers
A Phase 4 study testing оral intake of study drug capsules; study drug - Cardionat ® (trimethylhydrazinium propionate dihydrate), oral capsules 250 mg in people with Stroke, Not Specified as Hemorrhage or Infarction and Angina Pectoris, run by Burnasyan Federal Medical Biophysical Center at 1 site in Russia.
Trial summary
The objective of this study is to evaluate the long-term plasma and urine pharmacokinetic parameters of Cardionat®, capsules 250 mg, when used in healthy athlete volunteers. The study consists of four steps: Step 1. Screening - selecting healthy volunteers for inclusion in the study; Step 2. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Not Specified as Hemorrhage or Infarction, Angina Pectoris
- What is being tested?
- оral intake of study drug capsules; study drug - Cardionat ® (trimethylhydrazinium propionate dihydrate), oral capsules 250 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteRussia
- Study dates
- Nov 2016to 25 Oct 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers of both sexes aged 18 to 35 years old, caucasians;
- At least 1st sports category among adults;
- Verified diagnosis "healthy" according to a detailed medical history, and according to standard clinical, laboratory and instrumental methods of examination;
- BMI should be between 18.5 to 30 kg / m2;
- Signed Volunteer information sheet with the Informed consent form;
- Agreement of volunteer to use adequate methods of contraception (contraceptive reliability over 90%: the cervical cap with spermicide, diaphragm with spermicide, condoms, intrauterine devices), or total abstinence from sexual activity for the period of the study:
Show all 29Show fewer
- For women during the whole period from 30 days prior to the signing a Volunteer's information sheet with Informed consent form to 30 days after completion of study participation; in the period from the date of signing the Informed consent up to 30 days after completion of study participation barrier method of contraception should be used, if it is not the main method;
- For men during the whole period from signing a Volunteer's information sheet with the Informed consent form and until the completion of the study barrier method of contraception should be used.
- Non - inclusion criteria:
- Allergy in the past;
- Drug intolerance, hypersensitivity to any component of the study drug;
- Chronic cardiovascular, bronchopulmonary, endocrine or nervous systems diseases (including psychiatric disorders), and diseases of the gastrointestinal tract (GIT), liver, kidney, blood disorders, surgical interventions on the gastrointestinal tract (except appendectomy);
- Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency;
- Poor developed superficial veins of the forearm;
- Acute infectious, non-infectious and allergic diseases in less than 4 weeks prior to Visit 1 (screening);
- Positive blood test for HIV, syphilis, hepatitis B and C;
- Intake of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to 1/2 liters of beer, 200 ml wine or 50 ml of spiritus) alcoholism, drug addiction or drug abuse in the past;
- Smoking more than 10 cigarettes per day;
- Systolic blood pressure measured in the "sitting" position below 100 mm Hg or above 130 mm Hg and/or diastolic blood pressure below 60 mm Hg or above 90 mm Hg;
- Heart rate below 40 beats / min;
- Any deviation from the normal range of the results of clinical and laboratory tests (complete blood count, urinalysis, blood chemistry) and instrumental tests (ECG);
- Intake of any medicines, including any supplements, not agreed with study doctor;
- Blood donation: 0-49 ml - 0 days prior to Visit 1 (screening); 50-449 ml - in less than 30 days prior to Visit 1; 450-800 ml or more - less than 60 days prior to Visit 1; 800 ml - by the decision of the Chief Investigator, if the period of time prior to the visit 1 is more than 60 days;
- Plasmapheresis in less than 14 days prior to Visit 1;
- Participation in the competitions, where doping tests are required, while participating in this clinical trial (within 6 ± 2 months from the date of inclusion in the study - Visit 1 (Screening));
- Participation in the study of another medicinal product or medical device in less than 3 months prior to the study;
- Volunteer's inability or unwillingness to comply with the study protocol requirements;
- Any reason, which, according to researcher opinion, will impede the participation of volunteer in the study;
- Pregnant or lactating women (all women should have a negative pregnancy test results on the day of screening).
Who cannot join
- Unexpected and previously unknown adverse reactions (if it is related to support volunteer's health);
- Occurrence of SAEs;
- Acute diseases or conditions that are not SAEs, but according to researchers opinion, require exclusion of volunteers from the study;
- Decision to volunteer to withdraw from the study;
- Violation by volunteer of prescribed regimen and violation of research restrictions (by the decision of the investigator);
- Investigator's decision to exclude the volunteer from the study
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Budget Institution "State Scientific Center of Russian Federation - the Federal Medical Biophysical Center named after A I Burnazyan" (FSBI SSC FMBC name AI Burnazyan FMBA of Russia)
Moscow, 123098
About this study
Official title: Open-label Clinical Pharmacokinetic Study of Cardionat®, Capsules 250 mg (JSC Nizhpharm, Russia) Using in Health Athlete Volunteers
The objective of this study is to evaluate the long-term plasma and urine pharmacokinetic parameters of Cardionat®, capsules 250 mg, when used in healthy athlete volunteers.
The study consists of four steps:
- Step 1. Screening - selecting healthy volunteers for inclusion in the study;
- Step 2. Assignment in one of the study group, prescription of the study drug;
- Step 3. Samples collections for pharmacokinetic analysis;
- Step 4. Evaluation of pharmacokinetic data.
Read the detailed description
Cardionat is a structural analogue of gamma-butyrobetaine - a substance that is in every cell of the human body.
Under extra strain conditions cardionat restores the balance between oxygen delivery to the cell and cellular oxygen demand. Cardionat clears the intracellular accumulation of toxic metabolic products, protecting them from damage; also it has a general tonic effect. As a result of its use of the body acquires the ability to withstand stress and to quickly restore energy reserves. Because of these properties cardionat used to treat a variety of disorders of the cardiovascular system, disorders of blood supply to the brain, as well as to improve physical and mental performance. Synthesis of gamma-butyrobetaine, which has vasodilating properties, is highly increased as a result of reducing the concentration of carnitine.
In the case of acute ischemic myocardial injury cardionat slows the formation of necrotic areas, shortens the rehabilitation period.
In heart failure it increases myocardial contractility, increases exercise tolerance, reduces the frequency of angina attacks. In acute and chronic ischemic cerebrovascular disorders it improves blood circulation in the ischemic areas; it promotes blood redistribution increasing supply of the ischemic areas. It is effective in the case of vascular and dystrophic pathology of the ocular fundus. The drug eliminates functional disturbances of the nervous system in patients with chronic alcoholism during abstinence syndrome.
Pharmacokinetics After oral administration, the drug is rapidly absorbed. Bioavailability is 78%. The maximum plasma concentration is reached 1-2 hours after oral ingestion. The drug is metabolized in the body with the formation of two major metabolites, which are excreted by the kidneys. The half-life after oral intake is dose-dependent, and is usually 3 to 6 hours.
Indications for use:
As a part of combination treatment of coronary heart disease (angina, myocardial infarction), congestive heart failure and dyshormonal cardiomyopathy, as well as part of combination treatment of acute and chronic cerebrovascular disorders (stroke and cerebrovascular insufficiency).
Reduced working capacity; physical stress, including physical stress in athletes.
Abstinence syndrome in chronic alcohol abusers (in combination with specific alcohol abuse therapy).
In this study, volunteers will receive study medication in the form of oral capsules 250 mg.
The study drug will be applied as follows:
- Group 1: intake of study medication capsules orally at a dose of 1 g per day for 3 weeks - 14 volunteers (7 males and 7 females);
- Group 2: intake of study medication capsules at a dose of 2 g per day for 3 weeks - 14 volunteers (7 males and 7 females).
Study results will be published in "Drug Testing and Analysis" journal
- Being tested
- оral intake of study drug capsules; study drug - Cardionat ® (trimethylhydrazinium propionate dihydrate), oral capsules 250 mg
- Medical subject headings
- Stroke, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
оral intake of study drug capsules; study drug - Cardionat ® (trimethylhydrazinium propionate dihydrate), oral capsules 250 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| arm 1, Cardionat® | Experimental | oral intake of study drug capsules at a dose of 1 g per day for 3 weeks. Receives: Drug: оral intake of study drug capsules; study drug - Cardionat ® (trimethylhydrazinium propionate dihydrate), oral capsules 250 mg |
| arm 2, Cardionat® | Experimental | oral intake of study drug capsules at a dose of 2 g per day for 3 weeks. Receives: Drug: оral intake of study drug capsules; study drug - Cardionat ® (trimethylhydrazinium propionate dihydrate), oral capsules 250 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Data collected and assessed for each AE include type, duration, relationship to study drug, action taken and the outcome of the event. Registration of SAEs begins right after the first dose of study drug during the whole course of treatment.
Measured: 3 weeks after assignment of all eligible volunteers to one of the study groups (day 22th)
Secondary outcomes (10)
Cardionat® levels in blood
Test drug (Cardionat®) concentration in blood plasma of healthy volunteers after its oral administration during a period of 21 days (3 weeks) at doses of 1000 mg and 2000 mg (Group 1 and 2, respectively) by a validated HPLC method.
Measured: following days 0, 22, 26, 33, 40(twice), 41, 47(twice), 48, 54(twice), 55, 61(twice), 62, 75(twice), 76, 89(twice), 90, 103(twice), 104, 133(twcie), 134, 150(twice), 151
Cardionat® levels in urine
Test drug (Cardionat®) concentration in urine of healthy volunteers after its oral administration during a period of 21 days (3 weeks) at doses of 1000 mg and 2000 mg (Group 1 and 2, respectively) by a LC/MS/MS method using a liquid chromatograph Eksigent ekspert ultraLC 100 and a tandem mass spectrometer AB Sciex QTrap 3200.
Measured: following days 0, 22, 26, 33, 40(twice), 41, 47(twice), 48, 54(twice), 55, 61(twice), 62, 75(twice), 76, 89(twice), 90, 103(twice), 104, 133(twcie), 134, 150(twice), 151
Exercise load duration (Tel)
Exercise load duration (tel) is determined from the beginning of the test until termination by the athlete after the appearance of subjective impossibility to continue to carry the load - testing "to failure."
Measured: following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151
Time of onset of aerobic threshold (Tat)
Time of onset of aerobic threshold (tat) is a time-point of exercise load test where energy supplied primarily by aerobic glycolysis. It corresponds to a level of homeostasis, in which an increase in lactate occurs in the blood, exceeding a certain baseline level (up to this point lactate appearing in the muscles was completely neutralized by buffer systems). It is determined during the test at a value of the respiratory quotient of R ~ 0,85, corresponding to the appearance of the first bend on oxygen consumption-time curve (pulmonary ventilation).
Measured: following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151
Time of onset of the anaerobic threshold (Tant)
Time of onset of the anaerobic threshold (tant) is a time-point of exercise load test where anaerobic glycolysis becomes the leading mechanism of energy supply, and persistent accumulation of lactate with increase of lactate / pyruvate ration in muscle and arterial blood are observed. It is determined during the test at a value of the respiratory quotient of R ~ 1,01, corresponding to the appearance of the second bend on oxygen consumption-time curve (pulmonary ventilation).
Measured: following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151
Respiratory quotient (R)
Respiratory quotient (R) is a ratio of carbon dioxide volume emitted from the body to the volume of the absorbed oxygen during that time. Respiratory quotient is increased during intensive work load effort and lung hyperventilation, when additional previously binded CO2 is released from the body.
Measured: following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151
Maximum oxygen consumption (MOC)
The absolute criterion of achieving the level of maximum oxygen consumption is the presence of a "plateau" on a curve of oxygen consumption from the load power dependence. Indirect criteria of achieving the MOC include: a significant increase of lactate; Respiratory quotient ≥1,11 increase of heart rate to 180-200 beats/min.
Measured: following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151
The level of oxygen consumption in the aerobic threshold (V'O2AT)
The level of oxygen consumption in the aerobic threshold, AT (V'O2AT) is determined at the time of the onset of aerobic threshold
Measured: following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151
The level of oxygen consumption in the anaerobic threshold (V'O2ANT)
The level of oxygen consumption in the anaerobic threshold, ANT (V'O2ANT) is determined at the time of the onset of anaerobic threshold
Measured: following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151
Heart rate (HR)
Heart rate (HR) is registered during the whole testing period (HRres, HRat, HR ANT, HR max, HR recovery), which allows to get the pulse profile, not only for a particular athlete, but also for the contingent of the same sports and qualification level.
Measured: following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startNov 2016
- Primary completion25 Sep 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, Not Specified as Hemorrhage or InfarctionStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burnasyan Federal Medical Biophysical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758912
- Sponsor's protocol ID
- RU-FMBC-04-04-16
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2016
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rabin O, Uiba V, Miroshnikova Y, Zabelin M, Samoylov A, Karkischenko V, Semyonov S, Astrelina T, Razinkin S. Meldonium long-term excretion period and pharmacokinetics in blood and urine of healthy athlete volunteers. Drug Test Anal. 2019 Apr;11(4):554-566. doi: 10.1002/dta.2521. Epub 2018 Nov 12.
PubMed 30328291
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Clinical Pharmacokinetic Study of Cardionat®, Capsules 250 mg (JSC Nizhpharm, Russia) Using in Health Athlete Volunteers
- ClinicalTrials.gov ID
- NCT02758912
- Acronym / sponsor ID
- RU-FMBC-04-04-16
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Burnasyan Federal Medical Biophysical CenterOther government
- Study start
- Nov 2016
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the long-term plasma and urine pharmacokinetic parameters of Cardionat®, capsules 250 mg, when used in healthy athlete volunteers.
The study consists of four steps:
- Step 1. Screening - selecting healthy volunteers for inclusion in the study;
- Step 2. Assignment in one of the study group, prescription of the study drug;
- Step 3. Samples collections for pharmacokinetic analysis;
- Step 4. Evaluation of pharmacokinetic data.
Detailed description
Cardionat is a structural analogue of gamma-butyrobetaine - a substance that is in every cell of the human body.
Under extra strain conditions cardionat restores the balance between oxygen delivery to the cell and cellular oxygen demand. Cardionat clears the intracellular accumulation of toxic metabolic products, protecting them from damage; also it has a general tonic effect. As a result of its use of the body acquires the ability to withstand stress and to quickly restore energy reserves. Because of these properties cardionat used to treat a variety of disorders of the cardiovascular system, disorders of blood supply to the brain, as well as to improve physical and mental performance. Synthesis of gamma-butyrobetaine, which has vasodilating properties, is highly increased as a result of reducing the concentration of carnitine.
In the case of acute ischemic myocardial injury cardionat slows the formation of necrotic areas, shortens the rehabilitation period.
In heart failure it increases myocardial contractility, increases exercise tolerance, reduces the frequency of angina attacks. In acute and chronic ischemic cerebrovascular disorders it improves blood circulation in the ischemic areas; it promotes blood redistribution increasing supply of the ischemic areas. It is effective in the case of vascular and dystrophic pathology of the ocular fundus. The drug eliminates functional disturbances of the nervous system in patients with chronic alcoholism during abstinence syndrome.
Pharmacokinetics After oral administration, the drug is rapidly absorbed. Bioavailability is 78%. The maximum plasma concentration is reached 1-2 hours after oral ingestion. The drug is metabolized in the body with the formation of two major metabolites, which are excreted by the kidneys. The half-life after oral intake is dose-dependent, and is usually 3 to 6 hours.
Indications for use:
As a part of combination treatment of coronary heart disease (angina, myocardial infarction), congestive heart failure and dyshormonal cardiomyopathy, as well as part of combination treatment of acute and chronic cerebrovascular disorders (stroke and cerebrovascular insufficiency).
Reduced working capacity; physical stress, including physical stress in athletes.
Abstinence syndrome in chronic alcohol abusers (in combination with specific alcohol abuse therapy).
In this study, volunteers will receive study medication in the form of oral capsules 250 mg.
The study drug will be applied as follows:
- Group 1: intake of study medication capsules orally at a dose of 1 g per day for 3 weeks - 14 volunteers (7 males and 7 females);
- Group 2: intake of study medication capsules at a dose of 2 g per day for 3 weeks - 14 volunteers (7 males and 7 females).
Study results will be published in "Drug Testing and Analysis" journal
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm 1, Cardionat® | Experimental | Drug: оral intake of study drug capsules; study drug - Cardionat ® (trimethylhydrazinium propionate dihydrate), oral capsules 250 mgoral intake of study drug capsules at a dose of 1 g per day for 3 weeks. |
| arm 2, Cardionat® | Experimental | Drug: оral intake of study drug capsules; study drug - Cardionat ® (trimethylhydrazinium propionate dihydrate), oral capsules 250 mgoral intake of study drug capsules at a dose of 2 g per day for 3 weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (29 listed)
- Healthy volunteers of both sexes aged 18 to 35 years old, caucasians;
- At least 1st sports category among adults;
- Verified diagnosis "healthy" according to a detailed medical history, and according to standard clinical, laboratory and instrumental methods of examination;
- BMI should be between 18.5 to 30 kg / m2;
- Signed Volunteer information sheet with the Informed consent form;
Key exclusion criteria (6 listed)
- Unexpected and previously unknown adverse reactions (if it is related to support volunteer's health);
- Occurrence of SAEs;
- Acute diseases or conditions that are not SAEs, but according to researchers opinion, require exclusion of volunteers from the study;
- Decision to volunteer to withdraw from the study;
- Violation by volunteer of prescribed regimen and violation of research restrictions (by the decision of the investigator);
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 |
|---|---|---|
| оral intake of study drug capsules; study drug - Cardionat ® (trimethylhydrazinium propionate dihydrate), oral capsules 250 mg | Drug | arm 1, Cardionat®, arm 2, Cardionat® |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 3 weeks after assignment of all eligible volunteers to one of the study groups (day 22th)
Data collected and assessed for each AE include type, duration, relationship to study drug, action taken and the outcome of the event. Registration of SAEs begins right after the first dose of study drug during the whole course of treatment.
10 secondary outcomes
Cardionat® levels in blood
Time frame: following days 0, 22, 26, 33, 40(twice), 41, 47(twice), 48, 54(twice), 55, 61(twice), 62, 75(twice), 76, 89(twice), 90, 103(twice), 104, 133(twcie), 134, 150(twice), 151
Cardionat® levels in urine
Time frame: following days 0, 22, 26, 33, 40(twice), 41, 47(twice), 48, 54(twice), 55, 61(twice), 62, 75(twice), 76, 89(twice), 90, 103(twice), 104, 133(twcie), 134, 150(twice), 151
Exercise load duration (Tel)
Time frame: following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151
Time of onset of aerobic threshold (Tat)
Time frame: following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151
Time of onset of the anaerobic threshold (Tant)
Time frame: following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151
Respiratory quotient (R)
Time frame: following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151
Maximum oxygen consumption (MOC)
Time frame: following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151
The level of oxygen consumption in the aerobic threshold (V'O2AT)
Time frame: following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151
The level of oxygen consumption in the anaerobic threshold (V'O2ANT)
Time frame: following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151
Heart rate (HR)
Time frame: following days 22, 26, 33, 40, 41, 47, 48, 54, 55, 61, 62, 75, 76, 89, 90, 103, 104, 133, 134, 150, 151
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Background: PubMed 30328291Rabin O, Uiba V, Miroshnikova Y, Zabelin M, Samoylov A, Karkischenko V, Semyonov S, Astrelina T, Razinkin S. Meldonium long-term excretion period and pharmacokinetics in blood and urine of healthy athlete volunteers. Drug Test Anal. 2019 Apr;11(4):554-566. doi: 10.1002/dta.2521. Epub 2018 Nov 12.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing оral intake of study drug capsules; study drug - Cardionat ® (trimethylhydrazinium propionate dihydrate), oral capsules 250 mg in people with Stroke, Not Specified as Hemorrhage or Infarction and Angina Pectoris, run by Burnasyan Federal Medical Biophysical Center at 1 site 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 29 inclusion and 6 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 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Treatment-Emergent Adverse Events (time frame: 3 weeks after assignment of all eligible volunteers to one of the study groups (day 22th)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02758912, which also lists 1 linked publication.
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 10 Apr 2020.