HypertensionPhase 4NCT03626259
Losartan/Amlodipine on Hemodynamics Parameters and Arterial Stiffness in Arterial Hypertension
A Phase 4 study testing Losartan and Amlodipine and Losartan in people with Hypertension, run by Centro Universitario de Ciencias de la Salud, Mexico at 1 site in Mexico.
Trial summary
Systemic Arterial Hypertension (SAH) is a disease with a high prevalence in Mexico and worldwide. SAH is associated with an increase in cardiovascular morbidity and mortality, causing cardiovascular disease (CVD), heart failure (HF), as well as chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Losartan and Amlodipine and Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteMexico
- Study dates
- 6 Aug 2018to 14 Jun 2019
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of hypertension grade 1 or 2 according to the criteria of the American Heart Association (2017)
- Written informed consent
- Patients who are undergoing antihypertensive treatment and who, at the trial of the investigator and taking care of the health and safety of the patient, can undergo at least 2 weeks of washing prior to the visit of day 0 (it will be evaluated on a case-by-case basis).
Who cannot join
- Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥120 mmHg
- Diabetes Mellitus
- Treated with triple pharmacological therapy
- Untreated thyroid disease
- Total cholesterol >400mg/dl
- Triglycerides >400mg/dl
- Liver enzymes (alt and ast) more tan twice the normal range
- Glomerular filtration rate <60ml/min (Cockcroft-Gault)
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340
Fernando Grover Paez, PhD, 3310585200 ext. 33642, fgroverp@hotmail.com
About this study
Official title: Effect of the Administration of Losartan / Amlodipine in Fixed Combination Versus Losartan on Hemodynamic and Arterial Stiffness Parameters in Patients With Systemic Hypertension Grade 1 and 2
Systemic Arterial Hypertension (SAH) is a disease with a high prevalence in Mexico and worldwide. SAH is associated with an increase in cardiovascular morbidity and mortality, causing cardiovascular disease (CVD), heart failure (HF), as well as chronic kidney disease (CKD). Several of the physiopathological mechanisms observed are: the increase in cardiac output, central aortic pressure (CAP), pulse wave velocity (PWV) and peripheral vascular resistance (PVR), which leads to the generation of damage to the target organ. The identification not only of the peripheral arterial pressure, but also of these hemodynamic parameters and arterial stiffness would allow a better cardiovascular characterization of the patients. However, the measurements of hemodynamic parameters and arterial stiffness can vary during the 24 hours from individual to individual by all known mechanisms involved in the regulation of blood pressure such as cortisol, central nervous system, the peripheral nervous system, along with the renin angiotensin and aldosterone system, which are usually only measured in a single moment. Generally, the choice of drug in a patient with SAH is based only on the values of peripheral blood pressure at the time of the measurement. The use of oscillometric equipment such as the Mobil-O-Graph 24 allows to the investigators to know the hemodynamic and arterial stiffness behavior during 24 hours; therefore, this could favor the choice of the most appropriate antihypertensive drug, dose and administration time. The use of angiotensin II receptor antagonists (ARA II) At1 blockers such as losartan and calcium channel blockers (CCB) for instance amlodipine have shown a reduction in CAP and peripheral blood pressure respectively in patients with SAH. The most prescribed drugs in health units worldwide are enalapril, amlodipine, losartan and atenolol, of which the most used combination is losartan with amlodipine. There are no studies to date that allow investigators to identify the effect of the administration of losartan / amlodipine in a fixed combination form on the hemodynamic parameters and arterial stiffness of patients with SAH. Therefore, the objective of the present study is to evaluate the effect of this fixed combination versus losartan on hemodynamic and arterial stiffness parameters based on the behavior of these for 24 hours.
Read the detailed description
In the present investigation the investigators expect to know the effect of the administration of losartan / amlodipine in fixed combination versus losartan on hemodynamic parameters and arterial stiffness in patients with arterial hypertension grade 1 and 2. For this purpose the investigators will conduct a double-blind randomized trial, each group will be compose by 14 male and female patients, 40-65 years old, with hypertension, neither with diabetes nor being under triple pharmacological therapy. Randomization will determine who will receive the intervention during an 8- week trial (losartan/amlodipine in fixed combination capsule, 100mg/5mg 1 time daily or losartan capsule 100mg 1 time daily). The clinical findings and laboratory tests include a metabolic profile and biosafety, which will be at baseline and by the 8th week . Body weight, body fat, body mass index (BMI) and blood pressure will be determined during the initial and final visit, in addition to hemodynamics parameters of arterial stiffness like cardiac output, central aortic pressure (CAP), pulse wave velocity (PWV) and peripheral vascular resistance (PVR) by an oscillometric monitoring system via Mobil-O -Graph® 24. Adverse events and adherence to treatment will be documented. Statistical analysis: Mann-Whitney U Test and Wilcoxon exact test. It is considered with significance at p<0.05.
- Conditions
- Hypertension
- Being tested
- Losartan and Amlodipine, Losartan
- Keywords
- hypertension, losartan/amlodipine, 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.
Losartan and AmlodipineDrug
Also called Bicartial
Losartan and amlodipine in fixed combination capsules, 100mg/5mg. One time daily with the first bite of eat meal per 8 weeks
LosartanDrug
Losartan capsules, 100mg. One time daily with the first bite of eat meal per 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| losartan and amlodipine | Other | Individuals with SAH grade 1 or 2 without triple pharmacological therapy. Receives: Drug: Losartan and Amlodipine |
| Losartan | Active comparator | Individuals with SAH grade 1 or 2 without triple pharmacological therapy. Receives: Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Wave Velocity (PWVao)
Before and after intervention with oscillometric monitoring system via Mobil-O -Graph® 24. Maximum score 12 m/s
Measured: 56 days
Secondary outcomes (7)
Peripheral vascular resistance
Before and after intervention with oscillometric monitoring system via via Mobil-O -Graph®. Maximum score 1.8s*mmHg/ml
Measured: 56 days
Cardiac output
Before and after intervention with oscillometric monitoring system via via Mobil-O -Graph®. Maximum score 6.5L/min
Measured: 56 days
Pulse Pressure (PP)
Before and after intervention with oscillometric monitoring system via via Mobil-O -Graph® 24. Maximun score <75 mmHg
Measured: 56 days
Augmentation Index (AIx)
Before and after intervention with oscillometric monitoring system via via Mobil-O -Graph® 24. Maximum score 110%
Measured: 56 days
Systolic blood pressure
Before and after intervention using a digital manometer. Maximum score 160 mmHg
Measured: 56 days
Diastolic blood pressure
Before and after intervention using a digital manometer. Maximum score 100 mmHg
Measured: 56 days
Creatinine
Before and after intervention by spectrophotometry. Maximum score 1.3 mg/dl
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start6 Aug 2018
- Primary completion15 Jan 2019 (estimated)
- Study completion14 Jun 2019 (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
- Model description
- assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 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, Fernando Grover Paez, Centro Universitario de Ciencias de la Salud, Mexico
- Investigators
- Fernando Grover Paez, PhD, Principal investigator, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626259
- Sponsor's protocol ID
- CUCS-INTEC-MV-LOAM-001
- Status last verified
- Aug 2018
- First submitted
- 8 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Administration of Losartan / Amlodipine in Fixed Combination Versus Losartan on Hemodynamic and Arterial Stiffness Parameters in Patients With Systemic Hypertension Grade 1 and 2
- ClinicalTrials.gov ID
- NCT03626259
- Acronym / sponsor ID
- CUCS-INTEC-MV-LOAM-001
- Conditions
- Hypertension
- Keywords
- hypertension, losartan/amlodipine, arterial stiffness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, MexicoUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 15 Jan 2019 (estimated)
- Study completion
- 14 Jun 2019 (estimated)
- First posted
- 10 Aug 2018 (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.
Systemic Arterial Hypertension (SAH) is a disease with a high prevalence in Mexico and worldwide. SAH is associated with an increase in cardiovascular morbidity and mortality, causing cardiovascular disease (CVD), heart failure (HF), as well as chronic kidney disease (CKD). Several of the physiopathological mechanisms observed are: the increase in cardiac output, central aortic pressure (CAP), pulse wave velocity (PWV) and peripheral vascular resistance (PVR), which leads to the generation of damage to the target organ. The identification not only of the peripheral arterial pressure, but also of these hemodynamic parameters and arterial stiffness would allow a better cardiovascular characterization of the patients. However, the measurements of hemodynamic parameters and arterial stiffness can vary during the 24 hours from individual to individual by all known mechanisms involved in the regulation of blood pressure such as cortisol, central nervous system, the peripheral nervous system, along with the renin angiotensin and aldosterone system, which are usually only measured in a single moment. Generally, the choice of drug in a patient with SAH is based only on the values of peripheral blood pressure at the time of the measurement. The use of oscillometric equipment such as the Mobil-O-Graph 24 allows to the investigators to know the hemodynamic and arterial stiffness behavior during 24 hours; therefore, this could favor the choice of the most appropriate antihypertensive drug, dose and administration time. The use of angiotensin II receptor antagonists (ARA II) At1 blockers such as losartan and calcium channel blockers (CCB) for instance amlodipine have shown a reduction in CAP and peripheral blood pressure respectively in patients with SAH. The most prescribed drugs in health units worldwide are enalapril, amlodipine, losartan and atenolol, of which the most used combination is losartan with amlodipine. There are no studies to date that allow investigators to identify the effect of the administration of losartan / amlodipine in a fixed combination form on the hemodynamic parameters and arterial stiffness of patients with SAH. Therefore, the objective of the present study is to evaluate the effect of this fixed combination versus losartan on hemodynamic and arterial stiffness parameters based on the behavior of these for 24 hours.
Detailed description
In the present investigation the investigators expect to know the effect of the administration of losartan / amlodipine in fixed combination versus losartan on hemodynamic parameters and arterial stiffness in patients with arterial hypertension grade 1 and 2. For this purpose the investigators will conduct a double-blind randomized trial, each group will be compose by 14 male and female patients, 40-65 years old, with hypertension, neither with diabetes nor being under triple pharmacological therapy. Randomization will determine who will receive the intervention during an 8- week trial (losartan/amlodipine in fixed combination capsule, 100mg/5mg 1 time daily or losartan capsule 100mg 1 time daily). The clinical findings and laboratory tests include a metabolic profile and biosafety, which will be at baseline and by the 8th week . Body weight, body fat, body mass index (BMI) and blood pressure will be determined during the initial and final visit, in addition to hemodynamics parameters of arterial stiffness like cardiac output, central aortic pressure (CAP), pulse wave velocity (PWV) and peripheral vascular resistance (PVR) by an oscillometric monitoring system via Mobil-O -Graph® 24. Adverse events and adherence to treatment will be documented. Statistical analysis: Mann-Whitney U Test and Wilcoxon exact test. It is considered with significance at p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- assignment
| Arm | Type | Receives |
|---|---|---|
| losartan and amlodipine | Other | Drug: Losartan and AmlodipineIndividuals with SAH grade 1 or 2 without triple pharmacological therapy. |
| Losartan | Active comparator | Drug: LosartanIndividuals with SAH grade 1 or 2 without triple pharmacological therapy. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of hypertension grade 1 or 2 according to the criteria of the American Heart Association (2017)
- Written informed consent
- Patients who are undergoing antihypertensive treatment and who, at the trial of the investigator and taking care of the health and safety of the patient, can undergo at least 2 weeks of washing prior to the visit of day 0 (it will be evaluated on a case-by-case basis).
Key exclusion criteria (8 listed)
- Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥120 mmHg
- Diabetes Mellitus
- Treated with triple pharmacological therapy
- Untreated thyroid disease
- Total cholesterol >400mg/dl
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 |
|---|---|---|
| Losartan and AmlodipineAlso: BicartialLosartan and amlodipine in fixed combination capsules, 100mg/5mg. One time daily with the first bite of eat meal per 8 weeks | Drug | losartan and amlodipine |
| LosartanLosartan capsules, 100mg. One time daily with the first bite of eat meal per 8 weeks | Drug | Losartan |
Primary outcome
Pulse Wave Velocity (PWVao)
Time frame: 56 days
Before and after intervention with oscillometric monitoring system via Mobil-O -Graph® 24. Maximum score 12 m/s
7 secondary outcomes
Peripheral vascular resistance
Time frame: 56 days
Cardiac output
Time frame: 56 days
Pulse Pressure (PP)
Time frame: 56 days
Augmentation Index (AIx)
Time frame: 56 days
Systolic blood pressure
Time frame: 56 days
Diastolic blood pressure
Time frame: 56 days
Creatinine
Time frame: 56 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- 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.
Fernando Grover Paez, PhD principal investigator
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
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 Losartan and Amlodipine and Losartan in people with Hypertension, run by Centro Universitario de Ciencias de la Salud, Mexico at 1 site in 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 3 inclusion and 8 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 17 Aug 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Grover Paez, PhD (3310585200 ext. 33642, fgroverp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Wave Velocity (PWVao) (time frame: 56 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 17 Aug 2018.