HypertensionPhase 4NCT03038451
Efficacy and Safety of S-amlodipine 2,5 mg and 5 mg in Hypertension Patients
A Phase 4 study testing S-NOR (s-amlodipine) 2,5 mg & 5 mg tablet in people with Hypertension, run by Neutec Ar-Ge San ve Tic A.Ş at 1 site in Turkey (Türkiye).
Trial summary
s-amlodipine besylate 2,5 mg tablet will be administered to patients have not received any hypertension treatment before or have received any of anti-hypertensive mono-therapy for the first four weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- S-NOR (s-amlodipine) 2,5 mg & 5 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2013to 14 Feb 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients 18 years and older.
- Hypertension patients have not received any anti-hypertensive treatment before ( ≥ 140 mmHg MSSBP < 160 mmHg, ≥ 90 mmHg MSDBP < 100mmHg).
- Hypertension patients controlled with single medicine.
- Patients giving written informed consent without being under any influence.
Who cannot join
- Pregnant patients, nursing mothers or female patients who have potential for childbearing and do not use any effective contraceptive method.
- Allergy or hypersensitivity to dihydropyridines.
- Patients receive more than one anti-hypertensive medicine.
- Patients with seconder hypertension.
- Patients with severe hypertension, myocardial infarction, NYHA stage 2-4 cardiac insufficiency, history of cerebrovascular disease, past ischemic attack, encephalopathy, underwent coronary artery bypass surgery or percutaneous coronary intervention, second or third degree heart block or symptomatic arrhythmia without pacemaker, clinically significant heart valve disease, potential life-threatening or symptomatic arrhythmia, simultaneous unstable angina pectoris, type I diabetes mellitus, atrial fibrillation until the last 12 months.
- Uncontrolled type II diabetes mellitus.
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- Patients with significant liver disease (ALT, AST must be > 2XULN in beginning, patients with esophageal varices, portacaval shunt).
- Patients with significant kidney disease (GFR <60 ml/min according to Cockcroft-Gault formula).
- Patients with volume depletion.
- Patients with pancreas disease.
- Patients with gastrointestinal disease which may effect absorption.
- Drug/narcotic and alcohol abuse until the last 12 months.
- Patients with central nervous system disease and taking medicine for this reason.
- History of incompatibility with medical regimes or patients do not want to adhere the study protocol.
- Persons directly involved in the management of this protocol.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Medical Faculty Clinical Pharmacology Department
Istanbul, Fatih, 34093
About this study
Official title: Efficacy and Safety of S-amlodipine 2,5 mg and 5 mg in Hypertension Patients: Open-label, Local, Phase IV Study
s-amlodipine besylate 2,5 mg tablet will be administered to patients have not received any hypertension treatment before or have received any of anti-hypertensive mono-therapy for the first four weeks of treatment. By increasing dose, s-amlodipine besylate 5 mg tablet will be administered for the last four weeks (4-8 weeks).
- Conditions
- Hypertension
- Being tested
- S-NOR (s-amlodipine) 2,5 mg & 5 mg tablet
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-NOR (s-amlodipine) 2,5 mg & 5 mg tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| s-amlodipine besylate 2,5 and 5 mg tablets | Experimental | Not described Receives: Drug: S-NOR (s-amlodipine) 2,5 mg & 5 mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of change in systolic blood pressure up to 4th week of the treatment
Measured: 4 weeks
Secondary outcomes (6)
Evaluation of change in diastolic blood pressure up to 4th week of the treatment
Measured: 4 weeks
Evaluation of change in diastolic blood pressure up to 8th week of the treatment
Measured: 8 weeks
Evaluation of change in systolic blood pressure up to 8th week of the treatment
Measured: 8 weeks
Evaluation of change in systolic blood pressure from 4th to 8th week of the treatment
Measured: 4 to 8 weeks
Evaluation of change in diastolic blood pressure from 4th to 8th week of the treatment
Measured: 4 to 8 weeks
Evaluation of treatment response rates from 4th to 8th week of the treatment
Measured: 4 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start20 Mar 2013
- Primary completion14 Feb 2017
- Study completion14 Feb 2017
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
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
- NCT03038451
- Sponsor's protocol ID
- NEU-07.12
- Status last verified
- Jun 2018
- First submitted
- 14 Jan 2017
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Sen S, Demir M, Yigit Z, Uresin AY. Efficacy and Safety of S-Amlodipine 2.5 and 5 mg/d in Hypertensive Patients Who Were Treatment-Naive or Previously Received Antihypertensive Monotherapy. J Cardiovasc Pharmacol Ther. 2018 Jul;23(4):318-328. doi: 10.1177/1074248418769054. Epub 2018 Apr 12.
PubMed 29649885
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of S-amlodipine 2,5 mg and 5 mg in Hypertension Patients: Open-label, Local, Phase IV Study
- ClinicalTrials.gov ID
- NCT03038451
- Acronym / sponsor ID
- NEU-07.12
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2013 (actual)
- Primary completion
- 14 Feb 2017 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 31 Jan 2017 (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.
s-amlodipine besylate 2,5 mg tablet will be administered to patients have not received any hypertension treatment before or have received any of anti-hypertensive mono-therapy for the first four weeks of treatment. By increasing dose, s-amlodipine besylate 5 mg tablet will be administered for the last four weeks (4-8 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| s-amlodipine besylate 2,5 and 5 mg tablets | Experimental | Drug: S-NOR (s-amlodipine) 2,5 mg & 5 mg tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female outpatients 18 years and older.
- Hypertension patients have not received any anti-hypertensive treatment before ( ≥ 140 mmHg MSSBP < 160 mmHg, ≥ 90 mmHg MSDBP < 100mmHg).
- Hypertension patients controlled with single medicine.
- Patients giving written informed consent without being under any influence.
Key exclusion criteria (15 listed)
- Pregnant patients, nursing mothers or female patients who have potential for childbearing and do not use any effective contraceptive method.
- Allergy or hypersensitivity to dihydropyridines.
- Patients receive more than one anti-hypertensive medicine.
- Patients with seconder hypertension.
- Patients with severe hypertension, myocardial infarction, NYHA stage 2-4 cardiac insufficiency, history of cerebrovascular disease, past ischemic attack, encephalopathy, underwent coronary artery bypass surgery or percutaneous coronary intervention, second or third degree heart block or symptomatic arrhythmia without pacemaker, clinically significant heart valve disease, potential life-threatening or symptomatic arrhythmia, simultaneous unstable angina pectoris, type I diabetes mellitus, atrial fibrillation 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 |
|---|---|---|
| S-NOR (s-amlodipine) 2,5 mg & 5 mg tablet | Drug | s-amlodipine besylate 2,5 and 5 mg tablets |
Primary outcome
Evaluation of change in systolic blood pressure up to 4th week of the treatment
Time frame: 4 weeks
6 secondary outcomes
Evaluation of change in diastolic blood pressure up to 4th week of the treatment
Time frame: 4 weeks
Evaluation of change in diastolic blood pressure up to 8th week of the treatment
Time frame: 8 weeks
Evaluation of change in systolic blood pressure up to 8th week of the treatment
Time frame: 8 weeks
Evaluation of change in systolic blood pressure from 4th to 8th week of the treatment
Time frame: 4 to 8 weeks
Evaluation of change in diastolic blood pressure from 4th to 8th week of the treatment
Time frame: 4 to 8 weeks
Evaluation of treatment response rates from 4th to 8th week of the treatment
Time frame: 4 to 8 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 15 Jun 2018.
- Results publication: PubMed 29649885Sen S, Demir M, Yigit Z, Uresin AY. Efficacy and Safety of S-Amlodipine 2.5 and 5 mg/d in Hypertensive Patients Who Were Treatment-Naive or Previously Received Antihypertensive Monotherapy. J Cardiovasc Pharmacol Ther. 2018 Jul;23(4):318-328. doi: 10.1177/1074248418769054. Epub 2018 Apr 12.
- 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.
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 S-NOR (s-amlodipine) 2,5 mg & 5 mg tablet in people with Hypertension, run by Neutec Ar-Ge San ve Tic A.Ş at 1 site in Turkey (Türkiye).
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 15 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 15 Jun 2018. 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 Turkey (Türkiye). 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?
Evaluation of change in systolic blood pressure up to 4th week of the 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?
On the ClinicalTrials.gov record for NCT03038451, 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 15 Jun 2018.