HypertensionPhase 4NCT04457323
S-Metoprolol XR 25-50 mg Tablets vs Metoprolol Zok 50-100 mg Tablets in Hypertension Patients.
A Phase 4 study testing Metoprolol in people with Hypertension, run by Neutec Ar-Ge San ve Tic A.Ş.
Trial summary
The aim of this study is to compare the efficacy and safety of S-Metoprolol XR 25 and 50 mg Film Coated Tablets and Beloc® (Metoprolol) Zok 50 and 100 mg Controlled Release Film Tablets administered once daily, in the treatment of hypertension. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Metoprolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2022to 15 Dec 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients: between the ages of 18-70,
- Stage 1 and 2 hypertension patients who have not received any antihypertensive treatment in the past month * (≥ 140 mmHg SKB <180 mmHg, ≥ 90 mmHg DKB <110 mmHg,
- Patients with minute heart rate ≥ 70 / min,
- Patients followed up with outpatient treatment,
- Patients who give written informed consent without any influence, (Stage 1 Hypertension; SKB: 140-159 mmHg and DKB: 90-99 mmHg, Stage 2 Hypertension; SKB: 160--179 mmHg and DKB: 100--109 mmHg)
Who cannot join
- Pregnant patients or breastfeeding mothers or women with childbearing potential who do not use any effective contraceptive methods,
- Patients with allergies or hypersensitivity to betabloker drugs,
- Patients who have received antihypertensive treatment in the past month,
- Patients with secondary hypertension,
- Patients who were followed up for the following diseases from the beginning of the study until the last 12 months,
- Severe hypertension (SKB> 180 mmHg and / or DKB> 110 mmHg),
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- Myocardial infarction,
- NYHA stage 2-4 heart failure,
- Patients with a history of cerebrovascular disease, previous ischemic attack, encephalopathy,
- Patients undergoing percutaneous coronary intervention or coronary artery bypass surgery,
- 2nd or 3rd degree heart block or symptomatic arrhythmia without pacemaker,
- Clinically significant heart valve disease,
- Simultaneous life-threatening potential or symptomatic arrhythmia,
- Simultaneous unstable angina pectoris,
- Type 1 DM,
- Atrial fibrillation,
- Uncontrollable Type 2 DM (HbA1C> 7%),
- Patients with significant liver disease (initial ALT, AST> 2xULN, esophageal varices, portocaval shunt),
- Patients with significant kidney disease (GFR <60 ml / min according to the Cockcroft-Gault formula),
- Patients with volume depletion,
- Patients with pancreatic disease,
- Patients with gastrointestinal disease affecting absorption,
- Drug/substance and alcohol abuse in the last 12 months,
- Patients with central nervous system disease and using drugs for this reason,
- A history of incompatibility with medical regimens, or patients' unwillingness to comply with the study protocol,
- Patients directly involved in the management of this protocol.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Efficacy and Safety of S-Metoprolol XR 25-50 mg Tablets and Metoprolol Zok 50-100 mg Tablets in Hypertensive Patients.
The aim of this study is to compare the efficacy and safety of S-Metoprolol XR 25 and 50 mg Film Coated Tablets and Beloc® (Metoprolol) Zok 50 and 100 mg Controlled Release Film Tablets administered once daily, in the treatment of hypertension.
- Conditions
- Hypertension
- Being tested
- Metoprolol
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoprololDrug
Also called S-metoprolol
S-Metoprolol XR 25 mg and 50 mg Film Coated Tablets
MetoprololDrug
Beloc® (Metoprolol) Zok 50 mg and 100 mg Controlled Release Film Tablets
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | S-Metoprolol XR 25 mg Film Coated Tablets (first four weeks) S-Metoprolol XR 50 mg Film Coated Tablets (second four weeks) Receives: Drug: Metoprolol |
| REFERENCE | Active comparator | Beloc® (Metoprolol) Zok 50 mg Controlled Release Film Tablets (first four weeks) Beloc® (Metoprolol) Zok 100 mg Controlled Release Film Tablets (second four weeks) Receives: Drug: Metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic and diastolic blood pressure between 0-4 weeks of treatment
Measured: 4-weeks
Secondary outcomes (5)
Change in systolic blood pressure between 0-8 weeks of treatment.
Measured: 8-weeks
Change in diastolic blood pressure between 0-8 weeks of treatment.
Measured: 8-weeks
Change in diastolic blood pressure between 4-8 weeks of treatment.
Measured: 4-weeks
Change in sistolic blood pressure between 4-8 weeks of treatment.
Measured: 8-weeks
Treatment response rates
Target blood pressure values were determined by decreasing more than 20mmHg in systolic blood pressure and / or decreasing more than 10mmHg in diastolic pressure (under systolic 140 mmHg, below diastolic 90 mmHg).
Measured: 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start15 Jan 2022 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.Ş
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457323
- Sponsor's protocol ID
- NEU-03.17
- Status last verified
- Dec 2021
- First submitted
- 25 Jun 2020
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of S-Metoprolol XR 25-50 mg Tablets and Metoprolol Zok 50-100 mg Tablets in Hypertensive Patients.
- ClinicalTrials.gov ID
- NCT04457323
- Acronym / sponsor ID
- NEU-03.17
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2022 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 7 Jul 2020 (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.
The aim of this study is to compare the efficacy and safety of S-Metoprolol XR 25 and 50 mg Film Coated Tablets and Beloc® (Metoprolol) Zok 50 and 100 mg Controlled Release Film Tablets administered once daily, in the treatment of hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: MetoprololS-Metoprolol XR 25 mg Film Coated Tablets (first four weeks) S-Metoprolol XR 50 mg Film Coated Tablets (second four weeks) |
| REFERENCE | Active comparator | Drug: MetoprololBeloc® (Metoprolol) Zok 50 mg Controlled Release Film Tablets (first four weeks) Beloc® (Metoprolol) Zok 100 mg Controlled Release Film Tablets (second four weeks) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients: between the ages of 18-70,
- Stage 1 and 2 hypertension patients who have not received any antihypertensive treatment in the past month * (≥ 140 mmHg SKB <180 mmHg, ≥ 90 mmHg DKB <110 mmHg,
- Patients with minute heart rate ≥ 70 / min,
- Patients followed up with outpatient treatment,
- Patients who give written informed consent without any influence, (Stage 1 Hypertension; SKB: 140-159 mmHg and DKB: 90-99 mmHg, Stage 2 Hypertension; SKB: 160--179 mmHg and DKB: 100--109 mmHg)
Key exclusion criteria (26 listed)
- Pregnant patients or breastfeeding mothers or women with childbearing potential who do not use any effective contraceptive methods,
- Patients with allergies or hypersensitivity to betabloker drugs,
- Patients who have received antihypertensive treatment in the past month,
- Patients with secondary hypertension,
- Patients who were followed up for the following diseases from the beginning of the study until the last 12 months,
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 |
|---|---|---|
| MetoprololAlso: S-metoprololS-Metoprolol XR 25 mg and 50 mg Film Coated Tablets | Drug | Test |
| MetoprololBeloc® (Metoprolol) Zok 50 mg and 100 mg Controlled Release Film Tablets | Drug | REFERENCE |
Primary outcome
Change in systolic and diastolic blood pressure between 0-4 weeks of treatment
Time frame: 4-weeks
5 secondary outcomes
Change in systolic blood pressure between 0-8 weeks of treatment.
Time frame: 8-weeks
Change in diastolic blood pressure between 0-8 weeks of treatment.
Time frame: 8-weeks
Change in diastolic blood pressure between 4-8 weeks of treatment.
Time frame: 4-weeks
Change in sistolic blood pressure between 4-8 weeks of treatment.
Time frame: 8-weeks
Treatment response rates
Time frame: 4-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoprolol in people with Hypertension, run by Neutec Ar-Ge San ve Tic A.Ş.
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 26 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 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neutec RD (00905051747902, iremkaraman@neutecrdc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic and diastolic blood pressure between 0-4 weeks of treatment (time frame: 4-weeks). 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 10 Dec 2021.