Resistant Arterial HypertensionSAGANCT05899920
Clinical One-stage Controlled Study of reSistant Arterial Hypertension for the desiGning of a personAlized Approach to Therapy
A study testing Blood samples will be taken for pharmacokinetics and pharmacogenetics in people with Resistant Arterial Hypertension, run by Ryazan State Medical University at 1 site in Russia.
Trial summary
This study was planned to assess the concentration of antihypertensive drugs in the blood plasma in patients with controlled and uncontrolled arterial hypertension. Methods: it is planned to include patients with arterial hypertension taking 3 antihypertensive drugs (indapanide, lisinopril or valsartan, amlodipine). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resistant Arterial Hypertension
- What is being tested?
- Blood samples will be taken for pharmacokinetics and pharmacogenetics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteRussia
- Study dates
- 11 Mar 2022to 31 Dec 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form;
- An established diagnosis of AH based on the Clinical Guidelines "Arterial hyperten-sion in adults", approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation, 2020;
- Mandatory patient compliance with recommendations for lifestyle modification in accordance with the Clinical Guidelines "Arterial hypertension in adults", approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation, 2020 .
- Regular administration of any two antihypertensive drugs (lisinopril, amlodipine, valsartan) in combination with indapamide for a month, possibly in fixed combinations, in stable dosages;
- Fertile female patients must use proper methods of contraception throughout the study period.
Who cannot join
- Patient's connection with the organization or conducting of the study;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Ryzan State Medical University
Ryazan, 390026
Sergey V Seleznev, MD, PhD, +79105749526, sv.seleznev@gmail.com
Alexey V Shchulkin, MD, PhD, +79209520024, alekseyshulkin@rambler.ru
About this study
This study was planned to assess the concentration of antihypertensive drugs in the blood plasma in patients with controlled and uncontrolled arterial hypertension. Methods: it is planned to include patients with arterial hypertension taking 3 antihypertensive drugs (indapanide, lisinopril or valsartan, amlodipine). Based on the results of 24-hour blood pressure monitoring, the patients will be randomized into two groups: The first group - the patients with controlled AH; The second group - the patients with uncontrolled AH. Venous blood was taken in both groups of the patients in the morning before and 2 hours after taking drugs to assess the concentration of lisinopril, amlodipine, valsartan and indapamide. Concentation of assesed antihypertensive drugs will be compared in both groups.
- Conditions
- Resistant Arterial Hypertension
- Being tested
- Blood samples will be taken for pharmacokinetics and pharmacogenetics
- Keywords
- antihypertensive drugs, concentration, HPLC MS/MS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples will be taken for pharmacokinetics and pharmacogeneticsDiagnostic test
To assess antihypertensive drugs concentration (lisinopril, valsartan, amlodipine, indapamide
| Study group | Role | What they receive |
|---|---|---|
| Controlled arterial hypertension | Active comparator | Controlled arterial hypertension according the results of 24-hour blood pressure monitoring.
Blood samples will be taken for pharmacokinetics and pharmacogenetics Receives: Diagnostic Test: Blood samples will be taken for pharmacokinetics and pharmacogenetics |
| Uncontrolled arterial hypertension | Experimental | Uncontrolled arterial hypertension according the results of 24-hour blood pressure monitoring.
Blood samples will be taken for pharmacokinetics and pharmacogenetics Receives: Diagnostic Test: Blood samples will be taken for pharmacokinetics and pharmacogenetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of lisinopril, valsartan, amlodipin, indapamide, metoprolol
Number of Participants with antihypertensive drug concentraion below the limit of quantitative determination
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start11 Mar 2022
- Primary completion11 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ryazan State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899920
- Sponsor's protocol ID
- SAGA-01
- Acronym
- SAGA
- Status last verified
- Apr 2024
- First submitted
- 2 May 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical One-stage Controlled Study of reSistant Arterial Hypertension for the desiGning of a personAlized Approach to Therapy
- ClinicalTrials.gov ID
- NCT05899920
- Acronym / sponsor ID
- SAGA / SAGA-01
- Conditions
- Resistant Arterial Hypertension
- Keywords
- antihypertensive drugs, concentration, HPLC MS/MS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Ryazan State Medical UniversityUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 11 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Jun 2023 (actual)
- 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.
This study was planned to assess the concentration of antihypertensive drugs in the blood plasma in patients with controlled and uncontrolled arterial hypertension. Methods: it is planned to include patients with arterial hypertension taking 3 antihypertensive drugs (indapanide, lisinopril or valsartan, amlodipine). Based on the results of 24-hour blood pressure monitoring, the patients will be randomized into two groups: The first group - the patients with controlled AH; The second group - the patients with uncontrolled AH. Venous blood was taken in both groups of the patients in the morning before and 2 hours after taking drugs to assess the concentration of lisinopril, amlodipine, valsartan and indapamide. Concentation of assesed antihypertensive drugs will be compared in both groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled arterial hypertension | Active comparator | Diagnostic Test: Blood samples will be taken for pharmacokinetics and pharmacogeneticsControlled arterial hypertension according the results of 24-hour blood pressure monitoring. Blood samples will be taken for pharmacokinetics and pharmacogenetics |
| Uncontrolled arterial hypertension | Experimental | Diagnostic Test: Blood samples will be taken for pharmacokinetics and pharmacogeneticsUncontrolled arterial hypertension according the results of 24-hour blood pressure monitoring. Blood samples will be taken for pharmacokinetics and pharmacogenetics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent form;
- An established diagnosis of AH based on the Clinical Guidelines "Arterial hyperten-sion in adults", approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation, 2020;
- Mandatory patient compliance with recommendations for lifestyle modification in accordance with the Clinical Guidelines "Arterial hypertension in adults", approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation, 2020 .
- Regular administration of any two antihypertensive drugs (lisinopril, amlodipine, valsartan) in combination with indapamide for a month, possibly in fixed combinations, in stable dosages;
- Fertile female patients must use proper methods of contraception throughout the study period.
Key exclusion criteria (2 listed)
- Patient's connection with the organization or conducting of the study;
- Pregnancy.
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 |
|---|---|---|
| Blood samples will be taken for pharmacokinetics and pharmacogeneticsTo assess antihypertensive drugs concentration (lisinopril, valsartan, amlodipine, indapamide | Diagnostic test | Controlled arterial hypertension, Uncontrolled arterial hypertension |
Primary outcome
Plasma Concentration of lisinopril, valsartan, amlodipin, indapamide, metoprolol
Time frame: day 1
Number of Participants with antihypertensive drug concentraion below the limit of quantitative determination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples will be taken for pharmacokinetics and pharmacogenetics in people with Resistant Arterial Hypertension, run by Ryazan State Medical University 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Apr 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergey V Seleznev, MD, PhD (+79105749526, sv.seleznev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Concentration of lisinopril, valsartan, amlodipin, indapamide, metoprolol (time frame: day 1). 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 24 Apr 2024.