HypertensionPhase 4NCT01409408
Comparison of Amlodipine and Aliskiren in Diabetic Hypertensive Patient With Blood Pressure Not Controlled by Losartan
A Phase 4 study testing Aliskiren and Amlodipine in people with Hypertension and Diabetes Mellitus, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
Trial summary
Assess if aliskiren is capable of enhancing vascular stiffness and endothelial function and compare theses effects and renin activity and concentration to those obtained with a calcium channel blocker, amlodipine, in patients with diabetes mellitus type 2 and blood pressure not controlled by 100 mg per day of losartan. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hypertension, Diabetes Mellitus
- What is being tested?
- Aliskiren and Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2011to Dec 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatorial patients with age between 40 and 70 years-old.
- Systemic arterial hypertension previously diagnosed and in use of two or less anti-hypertensive drugs in the preceding 4 weeks.
- Those patients without anti-hypertensive drug prescribed in the last 4 weeks with office systolic blood pressure between 140 and 159 mmHg and diastolic between 90 and 109 mmHg.
- Type 2 diabetes mellitus in use of oral medication that were not changed in the preceding 4 weeks. Glycated hemoglobin A1c less than 9.0%.
- Accepted the consent form.
Who cannot join
- Office systolic blood pressure equal or more than 180 mmHg, with or without treatment
- Office diastolic blood pressure equal or more than 110 mmHg, with or without treatment
- Evidences of a secondary cause for hypertension
- Glycated hemoglobin A1c > 9.0%
- Insulin therapy
- Chronic kidney disease of level 3 to 5 or in dialysis
Show all 9Show fewer
- Advanced target organ lesion, obtained by history or additional exams, and defined by: previous myocardial infarction, heart failure with ejection fraction less than 40%, cerebral vascular accident (ischemic or hemorrhagic), peripheral vascular disease (claudication or doppler with obstruction > 50% of vascular lumen), retinopathy with visual loss, symptomatic neuropathy.
- Cardiac arrhythmias, except for ectopic beats
- Any clinical or disabling condition that, in the opinion of the investigators, may confound or prejudice study results.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitario Pedro Ernesto
Rio de Janeiro, Rio de Janeiro, 20551030
About this study
Official title: Comparison Between Amlodipine and Aliskiren in Diabetic Hypertensive Patient With Blood Pressure Not Controlled by Losartan: Effects on Endothelial Function and Renin Concentration and Activity
Assess if aliskiren is capable of enhancing vascular stiffness and endothelial function and compare theses effects and renin activity and concentration to those obtained with a calcium channel blocker, amlodipine, in patients with diabetes mellitus type 2 and blood pressure not controlled by 100 mg per day of losartan.
Read the detailed description
Hypertension and diabetes mellitus are important risk factors for cardiovascular morbidity and mortality. Endothelial dysfunction and vascular rigidity are two pathophysiological mechanisms that may explain this relationship. Recent publications showed that both ACEi (angiotensin converting enzyme inhibitor) and ARB (angiotensin receptor blocker) were capable of improving vascular stiffness and endothelial function, and that these effects occurred despite blood pressure reduction. The major debate that persists is which drug to associate with ACEi or ARB to achieve blood pressure control in diabetic patients. Recent studies showed that even in patients under ACEi or ARB therapy there may be residual activity in the renin-angiotensin-aldosterone system (RASS). Direct renin inhibitors (DRI) are a new class of anti-hypertensive drugs that may complement the blockade of the RASS. Aliskiren was the first drug of this class that completed phase 3 studies and marketed in the 21th century. It's main advantage is that DRI may reduce angiotensin II and aldosterone synthesis without increasing renin levels. This study main objective is to assess if aliskiren is capable of enhancing vascular stiffness and endothelial function and compare theses effects to those obtained with a calcium channel blocker, amlodipine, in patients with diabetes mellitus type 2 and blood pressure not controlled by 100 mg per day of losartan. Vascular stiffness and endothelial function will be measured by: pulse wave velocity, augmentation index, brachial artery flow-mediated vasodilation, peripheral arterial tonometry (EndoPat). Another main objective is to compare plasma renin activity and concentration between those groups.
- Conditions
- Hypertension, Diabetes Mellitus
- Being tested
- Aliskiren, Amlodipine
- Keywords
- Hypertension, Diabetes Mellitus, Vascular stiffness, Endothelial function
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
Also called Rasilez.
300 mg of aliskiren daily for 8 weeks.
AmlodipineDrug
Also called Norvasc.
Amlodipine 5 mg daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren | Active comparator | Not described Receives: Drug: Aliskiren |
| Amlodipine | Active comparator | Not described Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular stiffness
Vascular stiffness will be measured by pulse wave velocity and augmentation index and compared between anlodipine and aliskiren.
Measured: 8 weeks
Endothelial function
Access endothelial function by peripheral arterial tonometry and brachial flow-mediated vasodilation and compare it between anlodipine and aliskiren.
Measured: 8 weeks
Renin activity and concentration
Access plasma renin activity and concentration and compare it between anlodipine and aliskiren.
Measured: 8 weeks
Secondary outcomes (6)
Compare drug effects in office blood pressure measurements to those obtained by home blood pressure monitoring and ambulatory blood pressure monitoring
Compare drug effects in office blood pressure measurements to those obtained by home blood pressure monitoring and ambulatory blood pressure monitoring
Measured: 8 weeks
Assess drugs effects in renin-angiotensin-aldosterone system (RAAS) and correlate it to renin concentration/mass and plasmatic renin activity
Assess drugs effects in RAAS and correlate it to renin concentration/mass and plasmatic renin activity
Measured: 8 weeks
Correlation of drug effects and uric acid plasmatic concentration
Correlation of drug effects and uric acid plasmatic concentration
Measured: 8 weeks
Correlation of drug effects and glomerular filtration rate
Correlation of drug effects and glomerular filtration rate
Measured: 8 weeks
Correlation of drug effects and microalbuminuria
Correlation of drug effects and microalbuminuria
Measured: 8 weeks
Correlation of drug effects and left ventricular mass and function (systolic and diastolic)
Correlation of drug effects and left ventricular mass and function (systolic and diastolic)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: Due to preliminary results of Altitude Trial.
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, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Pedro Ernesto
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Ronaldo A Gismondi, MD, DsC, Principal investigator, HUPedroernesto (UERJ)Mario F Neves, MD, PhD, Study director, HUPedroernesto (UERJ)Wille Oigman, MD, PhD, Study chair, HUPedroernesto (UERJ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409408
- Sponsor's protocol ID
- CAALIDH
- Status last verified
- Apr 2011
- First submitted
- 1 Aug 2011
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Amlodipine and Aliskiren in Diabetic Hypertensive Patient With Blood Pressure Not Controlled by Losartan: Effects on Endothelial Function and Renin Concentration and Activity
- ClinicalTrials.gov ID
- NCT01409408
- Acronym / sponsor ID
- CAALIDH
- Conditions
- Hypertension, Diabetes Mellitus
- Keywords
- Hypertension, Diabetes Mellitus, Vascular stiffness, Endothelial function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to preliminary results of Altitude Trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Universitario Pedro ErnestoUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 4 Aug 2011 (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.
Assess if aliskiren is capable of enhancing vascular stiffness and endothelial function and compare theses effects and renin activity and concentration to those obtained with a calcium channel blocker, amlodipine, in patients with diabetes mellitus type 2 and blood pressure not controlled by 100 mg per day of losartan.
Detailed description
Hypertension and diabetes mellitus are important risk factors for cardiovascular morbidity and mortality. Endothelial dysfunction and vascular rigidity are two pathophysiological mechanisms that may explain this relationship. Recent publications showed that both ACEi (angiotensin converting enzyme inhibitor) and ARB (angiotensin receptor blocker) were capable of improving vascular stiffness and endothelial function, and that these effects occurred despite blood pressure reduction. The major debate that persists is which drug to associate with ACEi or ARB to achieve blood pressure control in diabetic patients. Recent studies showed that even in patients under ACEi or ARB therapy there may be residual activity in the renin-angiotensin-aldosterone system (RASS). Direct renin inhibitors (DRI) are a new class of anti-hypertensive drugs that may complement the blockade of the RASS. Aliskiren was the first drug of this class that completed phase 3 studies and marketed in the 21th century. It's main advantage is that DRI may reduce angiotensin II and aldosterone synthesis without increasing renin levels. This study main objective is to assess if aliskiren is capable of enhancing vascular stiffness and endothelial function and compare theses effects to those obtained with a calcium channel blocker, amlodipine, in patients with diabetes mellitus type 2 and blood pressure not controlled by 100 mg per day of losartan. Vascular stiffness and endothelial function will be measured by: pulse wave velocity, augmentation index, brachial artery flow-mediated vasodilation, peripheral arterial tonometry (EndoPat). Another main objective is to compare plasma renin activity and concentration between those groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aliskiren | Active comparator | Drug: Aliskiren |
| Amlodipine | Active comparator | Drug: Amlodipine |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ambulatorial patients with age between 40 and 70 years-old.
- Systemic arterial hypertension previously diagnosed and in use of two or less anti-hypertensive drugs in the preceding 4 weeks.
- Those patients without anti-hypertensive drug prescribed in the last 4 weeks with office systolic blood pressure between 140 and 159 mmHg and diastolic between 90 and 109 mmHg.
- Type 2 diabetes mellitus in use of oral medication that were not changed in the preceding 4 weeks. Glycated hemoglobin A1c less than 9.0%.
- Accepted the consent form.
Key exclusion criteria (9 listed)
- Office systolic blood pressure equal or more than 180 mmHg, with or without treatment
- Office diastolic blood pressure equal or more than 110 mmHg, with or without treatment
- Evidences of a secondary cause for hypertension
- Glycated hemoglobin A1c > 9.0%
- Insulin therapy
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 |
|---|---|---|
| AliskirenAlso: Rasilez.300 mg of aliskiren daily for 8 weeks. | Drug | Aliskiren |
| AmlodipineAlso: Norvasc.Amlodipine 5 mg daily for 8 weeks. | Drug | Amlodipine |
Primary outcome
Vascular stiffness
Time frame: 8 weeks
Vascular stiffness will be measured by pulse wave velocity and augmentation index and compared between anlodipine and aliskiren.
Endothelial function
Time frame: 8 weeks
Access endothelial function by peripheral arterial tonometry and brachial flow-mediated vasodilation and compare it between anlodipine and aliskiren.
Renin activity and concentration
Time frame: 8 weeks
Access plasma renin activity and concentration and compare it between anlodipine and aliskiren.
6 secondary outcomes
Compare drug effects in office blood pressure measurements to those obtained by home blood pressure monitoring and ambulatory blood pressure monitoring
Time frame: 8 weeks
Assess drugs effects in renin-angiotensin-aldosterone system (RAAS) and correlate it to renin concentration/mass and plasmatic renin activity
Time frame: 8 weeks
Correlation of drug effects and uric acid plasmatic concentration
Time frame: 8 weeks
Correlation of drug effects and glomerular filtration rate
Time frame: 8 weeks
Correlation of drug effects and microalbuminuria
Time frame: 8 weeks
Correlation of drug effects and left ventricular mass and function (systolic and diastolic)
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
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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.
Ronaldo A Gismondi, MD, DsC principal investigator
HUPedroernesto (UERJ)
Mario F Neves, MD, PhD study director
HUPedroernesto (UERJ)
Wille Oigman, MD, PhD study chair
HUPedroernesto (UERJ)
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 Aliskiren and Amlodipine in people with Hypertension and Diabetes Mellitus, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
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 9 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: withdrawn, as of the sponsor's last update on 6 Mar 2012. 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 Brazil. 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 was withdrawn before enrolling participants, so there are no results.
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?
Vascular stiffness (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 6 Mar 2012.