HypertensionOMECARDIONCT06840964
Effect of Omega 3 in Hypertensive Patients
A study testing omega 3 ethyl esters at 90% in people with Hypertension and Dyslipidemia, run by Santa Maria de la Salud, Argentina at 1 site in Argentina.
Trial summary
This study aims to evaluate the impact of omega-3 (O3) supplementation in participants with high blood pressure and elevated triglycerides, focusing on cardiovascular risk factors. The research is particularly relevant, as O3 has been previously validated for its effects on abnormal lipid levels. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Hypertension, Dyslipidemia
- What is being tested?
- omega 3 ethyl esters at 90%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteArgentina
- Study dates
- 23 Mar 2023to 30 Aug 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signature of informed consent to participate. Without situations that potentially cause their departure from the country or the possibilities of follow-up during the study.
- Diagnosis of hypertriglyceridemia defined as mild 150-199 mg/ moderate 200-499 mg and severe more than 500 mg.
- Diagnosis of controlled arterial hypertension (BP ≤140/90 mm Hg) with stable pharmacological treatment (definitions of the Argentine Consensus on HTA, 2018).
- Women of childbearing age will be included only if they are under contraceptive treatment, adopted prior to the invitation to participate in the study (hormonal contraceptives (oral, injectable, implantable, etc., intrauterine devices).
Who cannot join
- Hypersensitivity to the active ingredient, or to soy, or allergy to fish. Liver failure. Pregnancy and breastfeeding. Active anticoagulant treatment. Women of childbearing age who do not use contraceptive methods prior to the invitation to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Effect of Acidified Omega 3 Esters (DHA+EPA) in Hypertensive Patients With Increased Triglycerides
This study aims to evaluate the impact of omega-3 (O3) supplementation in participants with high blood pressure and elevated triglycerides, focusing on cardiovascular risk factors. The research is particularly relevant, as O3 has been previously validated for its effects on abnormal lipid levels. The primary and secondary objectives aim to explore the effects of O3, as well as its potential therapeutic benefits in preventing cardiovascular diseases.
The main goal of this research is to investigate how O3 supplementation influences several key cardiovascular risk markers and overall vascular health. Specifically, the study will assess and analyze changes in cholesterol levels, triglycerides, uric acid, and blood glucose levels. Since inflammation plays a major role in heart disease, the study will examine how O3 affects inflammatory markers, including ferritin, high-sensitivity C-reactive protein (hsPCR), and the neutrophil-to-leukocyte ratio. These indicators help determine the level of systemic inflammation in the body. The study also aims to measure whether O3 supplementation improves vascular elasticity.
Read more
Apart from the primary cardiovascular effects, the study also aims to determine the tolerance levels of participants receiving O3 supplementation based on their cardiovascular profiles.
The study is based on the hypothesis that taking 2 grams of O3 daily for 12 weeks will lead to a significant reduction in triglyceride levels, lower inflammation markers, improved metabolic risk factors, and enhanced arterial elasticity, which can prevent or slow the progression of cardiovascular diseases. This hypothesis is supported by growing scientific evidence that suggests O3 fatty acids, particularly long-chain polyunsaturated fatty acids (DHA and EPA), have strong cardioprotective properties.
This is a clinical study that is planned in a prospective, interventional, randomized, placebo-controlled, and double-blind format. This means that participants will be randomly assigned to either the treatment group or the placebo group, and neither the participants nor the researchers will know who is receiving the actual treatment until the study ends.
This study is a pilot study, meaning it is a small-scale preliminary study designed to test the hypothesis before conducting a larger trial.
A total of 100 participants will be recruited. Participants will be randomly assigned into two groups: O3 group, receives omega-3 (O3) treatment; and control group, receives a placebo. The assignment will be 1:1 randomization, meaning each participant has an equal (50%) chance of receiving either the treatment or the placebo. The number of participants was chosen based on estimates that a 10% reduction in blood pressure measurements (mean arterial, brachial systolic, brachial diastolic, or central systolic) would be a meaningful outcome.
The duration of omega-3 intervention is based on previous research.
- Conditions
- Hypertension, Dyslipidemia
- Being tested
- omega 3 ethyl esters at 90%, Placebo
- Keywords
- hypertension, dyslipidemia, Triglycerides, omega-3 fatty acids
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega 3 ethyl esters at 90%Dietary supplement
2 grams/day of omega 3 capsules will be administered orally, for 12 weeks
PlaceboDietary supplement
Mygliol 812
| Study group | Role | What they receive |
|---|---|---|
| O3 Group | Active comparator | 2 grams/day of omega 3 capsules will be administered orally with food to optimize tolerance. (2 capsules). OMECAP 90 will be used (Registered trademark and approved by ANMAT). The capsules are provided free of charge by the manufacturer. It is recommended not to take on an empty stomach to improve tolerance. It comes in the form of capsules containing 1000 mg of omega 3 ethyl esters at 90%, gelatin 260 mg, glycerin 151 mg and purified water 39 mg. Receives: Dietary Supplement: omega 3 ethyl esters at 90% |
| Control Group | Placebo comparator | Mygliol 812 will be used, a mixture of various medium chain fatty acids (6 to 12 carbon atoms) that are present in various vegetable oils and do not have significant adverse effects. A capsule with the same characteristics as the O3 capsule will be administered and the same administration will be carried out. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in office systolic blood pressure from baseline
Mean change in office Systolic blood pressure from baseline in Millimeter Mercury, it measures average changes in office systolic blood pressure.
Blood pressure is assessed using standardized methods while the participant is seated and resting. The measurement is taken using a validated electronic BP monitor.
Measured: From enrollment to the end of treatment at 12 weeks
Mean change in office diastolic blood pressure from baseline
Mean change in office Diastolic blood pressure from baseline in Millimeter Mercury, it measures average changes in office diastolic blood pressure. Blood pressure is assessed using standardized methods while the participant is seated and resting. The measurement is taken using a validated electronic BP monitor.
Measured: From enrollment to the end of treatment at 12 weeks
Mean change in 24h and Daytime Ambulatory Systolic Arterial Blood Pressure from baseline
Mean change in 24h and Daytime Ambulatory Systolic blood pressure from baseline in Millimeter Mercury, it measures average changes in systolic blood pressure. Blood pressure is assessed using standardized methods for 24 hour ambulatory measurement using a validated BP device monitor.
Measured: From enrollment to the end of treatment at 12 weeks
Mean change in 24h and Daytime Ambulatory Diastolic Arterial Blood Pressure from baseline
Mean change in 24h and Daytime Ambulatory Diastolic blood pressure from baseline in Millimeter Mercury, it measures average changes in diastolic blood pressure. Blood pressure is assessed using standardized methods for 24 hour ambulatory measurement using a validated BP device monitor.
Measured: From enrollment to the end of treatment at 12 weeks
Mean change in resting pulse wave velocity from baseline
Measurement of pulse wave velocity (PWV) in meters per second. The calibrated and validated Mobil-O-Graph® portable monitor (IEM GmbH, Stolberg, Germany) will be used. This module is connected to a computer to record the brachial pulse wave. It performs pulse wave analysis based on the oscillometric method. The arterial pulsation generates pressure oscillations, which are transmitted to the blood pressure cuff and measured by the transducer to be interpreted by a specific software, recording the pulse wave of the brachial artery and deriving a pulse wave from the aortic arch.
All measurements will be performed on the left arm of the participant, at rest. Subjects will be instructed to be with empty bladder, not to drink coffee 60 minutes before gauging and alcoholic beverage in the last 24 hours.
Measured: From enrollment to the end of treatment at 12 weeks
Mean change in total cholesterol from baseline
Mean change in cholesterol in Milligram/deciliter from baseline, it measures average changes in cholesterol.
Measured: From enrollment to the end of treatment at 12 weeks
Mean change in high density lipoprotein from baseline
Mean change in high density lipoprotein (HDL) in Milligram/deciliter from baseline, it measures average changes in (HDL) cholesterol.
Measured: From enrollment to the end of treatment at 12 weeks
Mean change in triglycerides from baseline
Mean change in triglycerides in Milligram/deciliter from baseline, it measures average changes in plasma triglycerides.
Measured: From enrollment to the end of treatment at 12 weeks
Mean change in fasting blood sugar from baseline
Mean change in fasting blood sugar in Milligram/deciliter from baseline, it measures average changes in fasting blood sugar.
Measured: From enrollment to the end of treatment at 12 weeks
Mean change in high sensitive C reactive protein from baseline
Mean change in high sensitive C reactive protein (Hs-CRP) in Milligram/liter, it measures average changes in high sensitive C reactive protein (Hs-CRP).
Measured: From enrollment to the end of treatment at 12 weeks
Mean change in serum aspartate aminotransferase/serum glutamic-oxaloacetic transaminase from baseline
Serum aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) in units per liter (U/L).
Measured: From enrollment to the end of treatment at 12 weeks
Mean change in serum alanine transaminase/Serum Glutamic Pyruvic Transaminase from baseline
Serum alanine transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) in units per liter (U/L).
Measured: From enrollment to the end of treatment at 12 weeks
Mean change in fasting plasma insulin from baseline
Fasting plasma insulin after fasting for 8-12 hours. Results are reported in micro International Units per milliliter (uIU/mL)
Measured: From enrollment to the end of treatment at 12 weeks
Mean change in serum ferritin from baseline
Serum ferritin is measured in nanograms per milliliter (ng/mL)
Measured: From enrollment to the end of treatment at 12 weeks
Mean change in neutrophil-to-lymphocyte ratio from baseline
The neutrophil-to-lymphocyte ratio (NLR) is a measurement of the number of neutrophils compared to the number of lymphocytes in a blood sample. It's calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. An automated cell counter with mixed technologies performs the calculation.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (1)
Tolerability and safety
Presence or not, described by participants, of any of the known side effects , such as belching, indigestion, and diarrhea; or symptoms such as rash, itching, swelling, severe dizziness, or trouble breathing
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start23 Mar 2023
- Primary completion3 Jun 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Maria de la Salud, Argentina
- Sponsor type
- University, hospital or other
- Collaborators
- Gador S.A.
- Responsible party
- Sponsor
- Investigators
- Virginia C Kotliar, MD, MSc, PhD, Principal investigator, Santa Maria de la Salud. CONICET
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840964
- Sponsor's protocol ID
- 20220325
- Acronym
- OMECARDIO
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be shared with the applicant, along with a letter outlining the intended use of the data, which will be submitted to the research board for approval.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effect of Acidified Omega 3 Esters (DHA+EPA) in Hypertensive Patients With Increased Triglycerides
- ClinicalTrials.gov ID
- NCT06840964
- Acronym / sponsor ID
- OMECARDIO / 20220325
- Conditions
- Hypertension, Dyslipidemia
- Keywords
- hypertension, dyslipidemia, Triglycerides, omega-3 fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Santa Maria de la Salud, ArgentinaUniversity, hospital or other
- Collaborators
- Gador S.A.
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 21 Feb 2025 (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 aims to evaluate the impact of omega-3 (O3) supplementation in participants with high blood pressure and elevated triglycerides, focusing on cardiovascular risk factors. The research is particularly relevant, as O3 has been previously validated for its effects on abnormal lipid levels. The primary and secondary objectives aim to explore the effects of O3, as well as its potential therapeutic benefits in preventing cardiovascular diseases.
The main goal of this research is to investigate how O3 supplementation influences several key cardiovascular risk markers and overall vascular health. Specifically, the study will assess and analyze changes in cholesterol levels, triglycerides, uric acid, and blood glucose levels. Since inflammation plays a major role in heart disease, the study will examine how O3 affects inflammatory markers, including ferritin, high-sensitivity C-reactive protein (hsPCR), and the neutrophil-to-leukocyte ratio. These indicators help determine the level of systemic inflammation in the body. The study also aims to measure whether O3 supplementation improves vascular elasticity.
Apart from the primary cardiovascular effects, the study also aims to determine the tolerance levels of participants receiving O3 supplementation based on their cardiovascular profiles.
The study is based on the hypothesis that taking 2 grams of O3 daily for 12 weeks will lead to a significant reduction in triglyceride levels, lower inflammation markers, improved metabolic risk factors, and enhanced arterial elasticity, which can prevent or slow the progression of cardiovascular diseases. This hypothesis is supported by growing scientific evidence that suggests O3 fatty acids, particularly long-chain polyunsaturated fatty acids (DHA and EPA), have strong cardioprotective properties.
This is a clinical study that is planned in a prospective, interventional, randomized, placebo-controlled, and double-blind format. This means that participants will be randomly assigned to either the treatment group or the placebo group, and neither the participants nor the researchers will know who is receiving the actual treatment until the study ends.
This study is a pilot study, meaning it is a small-scale preliminary study designed to test the hypothesis before conducting a larger trial.
A total of 100 participants will be recruited. Participants will be randomly assigned into two groups: O3 group, receives omega-3 (O3) treatment; and control group, receives a placebo. The assignment will be 1:1 randomization, meaning each participant has an equal (50%) chance of receiving either the treatment or the placebo. The number of participants was chosen based on estimates that a 10% reduction in blood pressure measurements (mean arterial, brachial systolic, brachial diastolic, or central systolic) would be a meaningful outcome.
The duration of omega-3 intervention is based on previous research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| O3 Group | Active comparator | Dietary Supplement: omega 3 ethyl esters at 90%2 grams/day of omega 3 capsules will be administered orally with food to optimize tolerance. (2 capsules). OMECAP 90 will be used (Registered trademark and approved by ANMAT). The capsules are provided free of charge by the manufacturer. It is recommended not to take on an empty stomach to improve tolerance. It comes in the form of capsules containing 1000 mg of omega 3 ethyl esters at 90%, gelatin 260 mg, glycerin 151 mg and purified water 39 mg. |
| Control Group | Placebo comparator | Dietary Supplement: PlaceboMygliol 812 will be used, a mixture of various medium chain fatty acids (6 to 12 carbon atoms) that are present in various vegetable oils and do not have significant adverse effects. A capsule with the same characteristics as the O3 capsule will be administered and the same administration will be carried out. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signature of informed consent to participate. Without situations that potentially cause their departure from the country or the possibilities of follow-up during the study.
- Diagnosis of hypertriglyceridemia defined as mild 150-199 mg/ moderate 200-499 mg and severe more than 500 mg.
- Diagnosis of controlled arterial hypertension (BP ≤140/90 mm Hg) with stable pharmacological treatment (definitions of the Argentine Consensus on HTA, 2018).
- Women of childbearing age will be included only if they are under contraceptive treatment, adopted prior to the invitation to participate in the study (hormonal contraceptives (oral, injectable, implantable, etc., intrauterine devices).
Key exclusion criteria (1 listed)
- Hypersensitivity to the active ingredient, or to soy, or allergy to fish. Liver failure. Pregnancy and breastfeeding. Active anticoagulant treatment. Women of childbearing age who do not use contraceptive methods prior to the invitation to the study.
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 |
|---|---|---|
| omega 3 ethyl esters at 90%2 grams/day of omega 3 capsules will be administered orally, for 12 weeks | Dietary supplement | O3 Group |
| PlaceboMygliol 812 | Dietary supplement | Control Group |
Primary outcome
Mean change in office systolic blood pressure from baseline
Time frame: From enrollment to the end of treatment at 12 weeks
Mean change in office Systolic blood pressure from baseline in Millimeter Mercury, it measures average changes in office systolic blood pressure. Blood pressure is assessed using standardized methods while the participant is seated and resting. The measurement is taken using a validated electronic BP monitor.
Mean change in office diastolic blood pressure from baseline
Time frame: From enrollment to the end of treatment at 12 weeks
Mean change in office Diastolic blood pressure from baseline in Millimeter Mercury, it measures average changes in office diastolic blood pressure. Blood pressure is assessed using standardized methods while the participant is seated and resting. The measurement is taken using a validated electronic BP monitor.
Mean change in 24h and Daytime Ambulatory Systolic Arterial Blood Pressure from baseline
Time frame: From enrollment to the end of treatment at 12 weeks
Mean change in 24h and Daytime Ambulatory Systolic blood pressure from baseline in Millimeter Mercury, it measures average changes in systolic blood pressure. Blood pressure is assessed using standardized methods for 24 hour ambulatory measurement using a validated BP device monitor.
Mean change in 24h and Daytime Ambulatory Diastolic Arterial Blood Pressure from baseline
Time frame: From enrollment to the end of treatment at 12 weeks
Mean change in 24h and Daytime Ambulatory Diastolic blood pressure from baseline in Millimeter Mercury, it measures average changes in diastolic blood pressure. Blood pressure is assessed using standardized methods for 24 hour ambulatory measurement using a validated BP device monitor.
Mean change in resting pulse wave velocity from baseline
Time frame: From enrollment to the end of treatment at 12 weeks
Measurement of pulse wave velocity (PWV) in meters per second. The calibrated and validated Mobil-O-Graph® portable monitor (IEM GmbH, Stolberg, Germany) will be used. This module is connected to a computer to record the brachial pulse wave. It performs pulse wave analysis based on the oscillometric method. The arterial pulsation generates pressure oscillations, which are transmitted to the blood pressure cuff and measured by the transducer to be interpreted by a specific software, recording the pulse wave of the brachial artery and deriving a pulse wave from the aortic arch. All measurements will be performed on the left arm of the participant, at rest. Subjects will be instructed to be with empty bladder, not to drink coffee 60 minutes before gauging and alcoholic beverage in the last 24 hours.
Mean change in total cholesterol from baseline
Time frame: From enrollment to the end of treatment at 12 weeks
Mean change in cholesterol in Milligram/deciliter from baseline, it measures average changes in cholesterol.
Mean change in high density lipoprotein from baseline
Time frame: From enrollment to the end of treatment at 12 weeks
Mean change in high density lipoprotein (HDL) in Milligram/deciliter from baseline, it measures average changes in (HDL) cholesterol.
Mean change in triglycerides from baseline
Time frame: From enrollment to the end of treatment at 12 weeks
Mean change in triglycerides in Milligram/deciliter from baseline, it measures average changes in plasma triglycerides.
Mean change in fasting blood sugar from baseline
Time frame: From enrollment to the end of treatment at 12 weeks
Mean change in fasting blood sugar in Milligram/deciliter from baseline, it measures average changes in fasting blood sugar.
Mean change in high sensitive C reactive protein from baseline
Time frame: From enrollment to the end of treatment at 12 weeks
Mean change in high sensitive C reactive protein (Hs-CRP) in Milligram/liter, it measures average changes in high sensitive C reactive protein (Hs-CRP).
Mean change in serum aspartate aminotransferase/serum glutamic-oxaloacetic transaminase from baseline
Time frame: From enrollment to the end of treatment at 12 weeks
Serum aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) in units per liter (U/L).
Mean change in serum alanine transaminase/Serum Glutamic Pyruvic Transaminase from baseline
Time frame: From enrollment to the end of treatment at 12 weeks
Serum alanine transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) in units per liter (U/L).
Mean change in fasting plasma insulin from baseline
Time frame: From enrollment to the end of treatment at 12 weeks
Fasting plasma insulin after fasting for 8-12 hours. Results are reported in micro International Units per milliliter (uIU/mL)
Mean change in serum ferritin from baseline
Time frame: From enrollment to the end of treatment at 12 weeks
Serum ferritin is measured in nanograms per milliliter (ng/mL)
Mean change in neutrophil-to-lymphocyte ratio from baseline
Time frame: From enrollment to the end of treatment at 12 weeks
The neutrophil-to-lymphocyte ratio (NLR) is a measurement of the number of neutrophils compared to the number of lymphocytes in a blood sample. It's calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. An automated cell counter with mixed technologies performs the calculation.
1 secondary outcome
Tolerability and safety
Time frame: From enrollment to the end of treatment at 12 weeks
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 21 Feb 2025.
- Individual participant dataSharing planned: Yes. All collected IPD will be shared with the applicant, along with a letter outlining the intended use of the data, which will be submitted to the research board for approval.
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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.
Virginia C Kotliar, MD, MSc, PhD principal investigator
Santa Maria de la Salud. CONICET
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega 3 ethyl esters at 90% in people with Hypertension and Dyslipidemia, run by Santa Maria de la Salud, Argentina at 1 site in Argentina.
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 4 inclusion and 1 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 21 Feb 2025. 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 Argentina. 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. Some participants in this study may receive a placebo. 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?
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?
Mean change in office systolic blood pressure from baseline (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 15 primary outcomes in all. 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 21 Feb 2025.