Arterial HypertensionPhase 4NCT03294070
Fimasartan Plus Amlodipine on Hemodynamic Parameters and Arterial Stiffness in Patients With Hypertension
A Phase 4 study testing Fimasartan plus amlodipine besylate in people with Arterial Hypertension, run by Centro Universitario de Ciencias de la Salud, Mexico.
Trial summary
24-week open clinical trial to assess tolerability and effect on pressure, hemodynamic parameters and arterial rigidity of the combined treatment based on Fimasartan 60 mg and amlodipine besylate 5 mg given once daily in patients with arterial hypertension in stages 2-3 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Hypertension
- What is being tested?
- Fimasartan plus amlodipine besylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Aug 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject capable of understanding and signing voluntarily informed consent.
- Men and women aged 18-65 years.
- To have essential hypertension grade 2 or 3 according to the figures of diastolic blood pressure and / or systolic in office according to NOM-030 SSA.
- Reliable and willing to attend all study visits for the duration of the study and the follow-up according to the researcher's criteria.
- Patients on antihypertensive treatment and who in the judgment of the investigator and taking care of the health and safety of the patient can undergo 2 weeks of previous washing to the visit of day 0.
- -
Who cannot join
- Secondary arterial hypertension.
- Patients currently under treatment that at the discretion of the investigator can not be submitted to wash period.
- Severe renal insufficiency (glomerular filtration rate <30 mL / min / 1.73 m2)
- Moderate to severe hepatic impairment (Child-Pugh B or C classification).
- Hypersensitivity to any of the components of the research products
- Hepatobiliary obstruction
Show all 15Show fewer
- Myocardial infarction or severe coronary artery disease (including angina pectoris unstable) or clinically significant congestive heart failure within 6 months prior to visit to week-1 (selection).
- Left ventricular ejection fraction ≤40%
- Resting heart rate ≥90 lpm
- Thyroid disorder (treated subjects may be involved who are euthyroid)
- Clinically significant mitral or aortic valve disease (Grade ≥ 2) Hypertrophic obstructive cardiomyopathy
- 13. Clinically significant rhythm disorders 14. Clinically significant abnormal laboratory parameters in the investigator's judgment.
- 15. Concurrent treatment that may affect blood pressure and which can not be withdrawn in the opinion of the investigator. 16. A history of galactose intolerance or glucose-galactose malabsorption. 17. Pregnancy, breastfeeding. 18. Women capable of procreation DO NOT adopt an effective contraceptive method according to criterion of the investigator.
- 19. Patients participating in or participating in other research protocols within 3 months prior to week 1 visit (selection). 20. Another reason not previously specified but in the opinion of the investigator may contraindicate their participation in the study.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A 24-week Open-label Clinical Trial to Assess Tolerability and Antihypertensive Effect and in Hemodynamic Parameters and Arterial Stiffness of Fimasartan 60 mg Plus Amlodipine Besylate 5 mg Given Once a Day in Patients With Hypertension in Stadiums 2/3
24-week open clinical trial to assess tolerability and effect on pressure, hemodynamic parameters and arterial rigidity of the combined treatment based on Fimasartan 60 mg and amlodipine besylate 5 mg given once daily in patients with arterial hypertension in stages 2-3
Read the detailed description
A prospective, open clinical trial of a cohort of adult patients of both sexes with recent 2-3 years high blood pressure.
Intervention: Fimasartan 60 mg + amlodipine besylate 5 mg once daily
Purpose and justification of the study:
Systemic arterial hypertension (SAH) is a pathology that diminishes the hope and quality of life and is directly associated with the production or aggravation of other pathologies such as atherosclerosis, heart failure, ischemic heart disease and / or chronic kidney disease.
Several studies have shown that central pulse pressure (cPP) and central aortic pressure (CAP) are better predictors of cardiovascular disease, target organ damage and mortality, than the brachial or peripheral pulse pressure (pPP). More attention should be paid to central hemodynamics, since its values are those that directly impact the organs that are commonly damaged as a result of hypertension, brain, kidney and heart. (2) Current therapeutic strategies for SH, although partially effective, have not adequate control of tension figures in hypertensive patients, either due to lack of power, by their adverse effects or by requiring multiple shots that seriously compromise attachment to the treatment. Fimasartan is a medicine that belongs to the therapeutic class of the selective blockers of angiotensin II (AT 1) receptors, family of drugs with less adverse effects than other renin-angiotensin-aldosterone axis inhibitors, with potency adequate antihypertensive and additional beneficial effects on renal function, hypertrophy ventricular, atheromatosis and insulin sensitivity. Based on the physico-chemical characteristics of the Fimasartan and the results obtained in phase I-II and III studies in different populations, including the Mexican,favoring the adherence and control of blood pressure, it can be an effective and safe therapeutic option.
- Conditions
- Arterial Hypertension
- Being tested
- Fimasartan plus amlodipine besylate
- Keywords
- hemodynamic parameters, arterial stiffness
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fimasartan plus amlodipine besylateCombination product
Fimasartan 60 mg plus amlodipine besylate 5 mg or Fimasartan plus 12.5 mg HCTZ plus one 5 mg amlodipine besylate
| Study group | Role | What they receive |
|---|---|---|
| Fimasartan 60 mg + amlodipine besylate 5 mg | Experimental | Fimasartan 60 mg + amlodipine besylate 5 mg. In subjects with a DBP equal to or greater than 90 mmHg and / or SBP equal to or greater than 140 mmHg at week 8, the investigator will have the option, according to his clinical criteria, to add 12.5 mg of HCTZ QD (in these cases, the subject will receive one 60 mg Fimasartan tablet plus 12.5 mg HCTZ plus one 5 mg amlodipine besylate tablet. Receives: Combination Product: Fimasartan plus amlodipine besylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pulse wave velocity
The administration of combined dose-based treatment of 60 mg of fimasartan plus 5 mg of amlodipine besylate QD administered according to the treatment schedule for 24 weeks reduces VOPcf in Mexican Patients with Essential Arterial Hypertension grades 2 and 3
Measured: 24 week
Secondary outcomes (3)
Central Aortic Pressure
The administration of combined dose-based treatment of 60 mg of fimasartan plus 5 mg of amlodipine besylate QD administered according to the treatment schedule for 24 weeks reduces Central Aortic Pressure in Mexican Patients with Essential Arterial Hypertension grades 2 and 3
Measured: 24 week
Central Pulse Pressure
The administration of combined dose-based treatment of 60 mg of fimasartan plus 5 mg of amlodipine besylate QD administered according to the treatment schedule for 24 weeks reduces Central Pulse Pressure in Mexican Patients with Essential Arterial Hypertension grades 2 and 3
Measured: 24 week
Rising Index
The administration of combined dose-based treatment of 60 mg of fimasartan plus 5 mg of amlodipine besylate QD administered according to the treatment schedule for 24 weeks reduces Rising Index in Mexican Patients with Essential Arterial Hypertension grades 2 and 3
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study startSep 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernesto German Cardona Muñoz, Centro Universitario de Ciencias de la Salud, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294070
- Sponsor's protocol ID
- INTEC-1
- Status last verified
- Sep 2017
- First submitted
- 22 Sep 2017
- Last updated
- 26 Sep 2017
- 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 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week Open-label Clinical Trial to Assess Tolerability and Antihypertensive Effect and in Hemodynamic Parameters and Arterial Stiffness of Fimasartan 60 mg Plus Amlodipine Besylate 5 mg Given Once a Day in Patients With Hypertension in Stadiums 2/3
- ClinicalTrials.gov ID
- NCT03294070
- Acronym / sponsor ID
- INTEC-1
- Conditions
- Arterial Hypertension
- Keywords
- hemodynamic parameters, arterial stiffness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, MexicoUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 26 Sep 2017 (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.
24-week open clinical trial to assess tolerability and effect on pressure, hemodynamic parameters and arterial rigidity of the combined treatment based on Fimasartan 60 mg and amlodipine besylate 5 mg given once daily in patients with arterial hypertension in stages 2-3
Detailed description
A prospective, open clinical trial of a cohort of adult patients of both sexes with recent 2-3 years high blood pressure.
Intervention: Fimasartan 60 mg + amlodipine besylate 5 mg once daily
Purpose and justification of the study:
Systemic arterial hypertension (SAH) is a pathology that diminishes the hope and quality of life and is directly associated with the production or aggravation of other pathologies such as atherosclerosis, heart failure, ischemic heart disease and / or chronic kidney disease.
Several studies have shown that central pulse pressure (cPP) and central aortic pressure (CAP) are better predictors of cardiovascular disease, target organ damage and mortality, than the brachial or peripheral pulse pressure (pPP). More attention should be paid to central hemodynamics, since its values are those that directly impact the organs that are commonly damaged as a result of hypertension, brain, kidney and heart. (2) Current therapeutic strategies for SH, although partially effective, have not adequate control of tension figures in hypertensive patients, either due to lack of power, by their adverse effects or by requiring multiple shots that seriously compromise attachment to the treatment. Fimasartan is a medicine that belongs to the therapeutic class of the selective blockers of angiotensin II (AT 1) receptors, family of drugs with less adverse effects than other renin-angiotensin-aldosterone axis inhibitors, with potency adequate antihypertensive and additional beneficial effects on renal function, hypertrophy ventricular, atheromatosis and insulin sensitivity. Based on the physico-chemical characteristics of the Fimasartan and the results obtained in phase I-II and III studies in different populations, including the Mexican,favoring the adherence and control of blood pressure, it can be an effective and safe therapeutic option.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fimasartan 60 mg + amlodipine besylate 5 mg | Experimental | Combination Product: Fimasartan plus amlodipine besylateFimasartan 60 mg + amlodipine besylate 5 mg. In subjects with a DBP equal to or greater than 90 mmHg and / or SBP equal to or greater than 140 mmHg at week 8, the investigator will have the option, according to his clinical criteria, to add 12.5 mg of HCTZ QD (in these cases, the subject will receive one 60 mg Fimasartan tablet plus 12.5 mg HCTZ plus one 5 mg amlodipine besylate tablet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject capable of understanding and signing voluntarily informed consent.
- Men and women aged 18-65 years.
- To have essential hypertension grade 2 or 3 according to the figures of diastolic blood pressure and / or systolic in office according to NOM-030 SSA.
- Reliable and willing to attend all study visits for the duration of the study and the follow-up according to the researcher's criteria.
- Patients on antihypertensive treatment and who in the judgment of the investigator and taking care of the health and safety of the patient can undergo 2 weeks of previous washing to the visit of day 0.
Key exclusion criteria (15 listed)
- Secondary arterial hypertension.
- Patients currently under treatment that at the discretion of the investigator can not be submitted to wash period.
- Severe renal insufficiency (glomerular filtration rate <30 mL / min / 1.73 m2)
- Moderate to severe hepatic impairment (Child-Pugh B or C classification).
- Hypersensitivity to any of the components of the research products
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 |
|---|---|---|
| Fimasartan plus amlodipine besylateFimasartan 60 mg plus amlodipine besylate 5 mg or Fimasartan plus 12.5 mg HCTZ plus one 5 mg amlodipine besylate | Combination product | Fimasartan 60 mg + amlodipine besylate 5 mg |
Primary outcome
Reduction of pulse wave velocity
Time frame: 24 week
The administration of combined dose-based treatment of 60 mg of fimasartan plus 5 mg of amlodipine besylate QD administered according to the treatment schedule for 24 weeks reduces VOPcf in Mexican Patients with Essential Arterial Hypertension grades 2 and 3
3 secondary outcomes
Central Aortic Pressure
Time frame: 24 week
Central Pulse Pressure
Time frame: 24 week
Rising Index
Time frame: 24 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
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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 Fimasartan plus amlodipine besylate in people with Arterial Hypertension, run by Centro Universitario de Ciencias de la Salud, Mexico.
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 6 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: status not confirmed, as of the sponsor's last update on 26 Sep 2017. 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 Ernesto G Cardona -Muñoz, PhD (+52 3336173499, cameg1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of pulse wave velocity (time frame: 24 week). 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 26 Sep 2017.