HypertensionPhase 2/3AtheroliveNCT05636826
Olive Leaf Extracts in the Control of Hypertension
A Phase 2/3 study testing atherolive-drug in people with Hypertension, run by University of Monastir at 1 site in Tunisia.
Trial summary
This study will be carried out in 2 emergency departments (at the exit of the emergency room) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital). Patients over 18 years of age with: Arterial hypertension (hypertension). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Hypertension
- What is being tested?
- atherolive-drug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteTunisia
- Study dates
- 30 Dec 2023to 30 Dec 2025
- Phase
- Phase 2/3
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years of age with:
- Arterial hypertension (hypertension)
Who cannot join
- . Exclusion criteria: None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Cardiovascular Risk Factors:Hypertension
This study will be carried out in 2 emergency departments (at the exit of the emergency room) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).
Patients over 18 years of age with:
Arterial hypertension (hypertension).
Read the detailed description
This study will be carried out in 2 emergency departments (at the exit of the emergency room, patients included in the GR2 study) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).
All the population will benifit of a biological assessment which include:
Complete lipid profile, blood sugar, creatinine
one population will be randomized:
The population of patients with hypertension.
For patients in the hypertension group:
A blood pressure with holter will be carried out for 24 hours .
- Conditions
- Hypertension
- Being tested
- atherolive-drug, Placebo Atherolive
- Keywords
- hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atherolive-drugDrug
The patient will be assigned to one of two treatments (atherolive ) using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months.
Placebo AtheroliveDrug
The patient will be assigned to one of two treatments using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. Placebo will be prescribed at a dose of 400 mg, once a day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| atherolive-drug | Active comparator | The patient will be assigned to one of two treatments (atherolive ) using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherolive) will be prescribed at a dose of 400 mg, once a day for 3 months. Receives: Drug: atherolive-drug |
| atherolive-placebo | Placebo comparator | The patient will be assigned to one of two treatments using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherolive-placebo) will be prescribed at a dose of 400 mg, once a day for 3 months. Receives: Drug: Placebo Atherolive |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of blood pressure reduction
blood pressure reduction on 24 hours holter
Measured: 90 days
Secondary outcomes (1)
rate of lipid balance variation The secondary endpoint
variation in lipid reduction balance
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start30 Dec 2023
- Primary completion22 Nov 2024
- Study completion30 Dec 2025
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636826
- Sponsor's protocol ID
- ATHEROLIVE-HTA
- Acronym
- Atherolive
- Status last verified
- Nov 2024
- First submitted
- 23 Nov 2022
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Cardiovascular Risk Factors:Hypertension
- ClinicalTrials.gov ID
- NCT05636826
- Acronym / sponsor ID
- Atherolive / ATHEROLIVE-HTA
- Conditions
- Hypertension
- Keywords
- hypertension
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 5 Dec 2022 (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 will be carried out in 2 emergency departments (at the exit of the emergency room) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).
Patients over 18 years of age with:
Arterial hypertension (hypertension).
Detailed description
This study will be carried out in 2 emergency departments (at the exit of the emergency room, patients included in the GR2 study) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).
All the population will benifit of a biological assessment which include:
Complete lipid profile, blood sugar, creatinine
one population will be randomized:
The population of patients with hypertension.
For patients in the hypertension group:
A blood pressure with holter will be carried out for 24 hours .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atherolive-drug | Active comparator | Drug: atherolive-drugThe patient will be assigned to one of two treatments (atherolive ) using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherolive) will be prescribed at a dose of 400 mg, once a day for 3 months. |
| atherolive-placebo | Placebo comparator | Drug: Placebo AtheroliveThe patient will be assigned to one of two treatments using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherolive-placebo) will be prescribed at a dose of 400 mg, once a day for 3 months. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients over 18 years of age with:
- Arterial hypertension (hypertension)
Key exclusion criteria (1 listed)
- . Exclusion criteria: None.
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 |
|---|---|---|
| atherolive-drugThe patient will be assigned to one of two treatments (atherolive ) using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. | Drug | atherolive-drug |
| Placebo AtheroliveThe patient will be assigned to one of two treatments using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. Placebo will be prescribed at a dose of 400 mg, once a day for 3 months. | Drug | atherolive-placebo |
Primary outcome
rate of blood pressure reduction
Time frame: 90 days
blood pressure reduction on 24 hours holter
1 secondary outcome
rate of lipid balance variation The secondary endpoint
Time frame: 90 days
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 7 Jul 2026.
- Individual participant dataSharing planned: No
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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 2/3 study testing atherolive-drug in people with Hypertension, run by University of Monastir at 1 site in Tunisia.
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 2 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 7 Jul 2026. 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 Tunisia. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
rate of blood pressure reduction (time frame: 90 days). 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 7 Jul 2026.