HypertensionPhase 2NCT01480791
Aliskiren vs Hydrochlorothiazide in Hypertensive Type II Diabetic Patients on Resistance Arteries
A Phase 2 study testing Aliskiren vs. hydrochlorothiazide and Hydrochlorothiazide in people with Hypertension and Diabetes, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
Trial summary
This study will be performed only at the Jewish General Hospital. It will investigate the effect of treatment with aliskiren, an inhibitor of renin, a substance produced by the kidney that constricts arteries and raises blood pressure, on the blood vessels, specifically the arteries, of subjects who have diabetes and… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Diabetes
- What is being tested?
- Aliskiren vs. hydrochlorothiazide and Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 2
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hypertensive Group
- Diabetes mellitus (diagnosed for at least 6 months) will be defined by usual criteria based on basal glycemia or glucose tolerance test . Diabetes must be well controlled, with glycosylated hemoglobin below 0.08 (8%).
- Hypertension is defined as a mean SiSBP > 130 mmHg or SiDBP of 85-115mmHg at the screening visit, and after two weeks of placebo therapy. (Hypertension will be considered essential if there is no evidence of an underlying treatable cause after suitable clinical and laboratory assessment. Hypertensive patients may be taking any antihypertensive agent except a renin inhibitor. They may be taking an ACE inhibitor or an ARB, which will not be discontinued. If they have been on HCTZ, they are eligible to participate.
- Subjects are 30-70 years old
- Informed Consent obtained by patient
- Criteria for inclusion: Control Group
Show all 10Show fewer
- Diabetic defined as: hemoglobin A1C < 0.06 ( 6%) and / or fasting glycemia < 5.6mmol/L.
- Hypertensive defined as : SiSBP ≤120 mmHg and/or SiDBP ≤80mmHg
- Subjects are 30-70 years old
- Informed Consent obtained by patient
Who cannot join
- Uncontrolled diabetes ( defined as: preprandial glycemia usually above 10 mmol/L and glycosylated hemoglobin above 0.08).
- Renovascular hypertension
- History of malignant hypertension
- Sitting systolic blood pressure > 210 mmHg
- Cerebrovascular accident within the past year, or current transient ischemic attacks
- History of myocardial infarction, percutaneous coronary angioplasty or coronary artery bypass surgery
Show all 42Show fewer
- Clinically significant AV conduction disturbances and/or arrhythmias (e.g. second- or third-degree AV block; Sick-sinus syndrome or clinically significant bradycardia- resting heart rate < 45 beats/minute).
- Tachyarrhythmias; clinically significant arrhythmias
- Presence of an accessory bypass tract (e.g. Wolff-Parkinson-White syndrome)
- Angina pectoris
- Current or prior history of heart failure or known left ventricular ejection fraction ≤ 40%
- History of unexplained syncope or a known syncopal disorder (e.g., Stokes-Adams Syndrome)
- Presence or known history of hemodynamically significant obstructive valvular disease or hypertrophic cardiomyopathy
- Hypertensive patients already taking a renin inhibitor.
- Concomitant treatment
- Psychotropic or Antidepressant Agents
- Major psychotropic agents such as phenothiazines are not permitted. Chronic doses of antidepressants are not permitted.
- Oral Contraceptives are not allowed if the patient's hypertension was induced by this medication.
- Regular use of NSAID is permitted if taken regularly on a stable regimen. Aspirin in small doses (≤ 1 g/day) as a cardioprotective agent is permitted. Acetaminophen is permitted.
- Other Drugs
- Concomitant use of oral or inhaled steroids, ACTH, immunosuppressants or lithium are not allowed, nor are cyclosporine, quinidine, aliskiren available from the market.
- Laboratory Parameters
- Glycosylated hemoglobin above 0.08 (8%).
- Plasma creatinine concentration ≥ 200 μmol/L (adjusted for age and weight).
- Prior to patient entry, any hematuria should be evaluated, the etiology established/documented, and treatment rendered as appropriate.
- Off-treatment serum potassium concentration ≥ 5.5 mmol/L or ≤ 3.5 mmol/L
- AST (SGOT) or ALT (SGPT) > 2 x normal upper limit, and if clinically significant
- Clinically significant laboratory values outside of the established normal range including but not limited to any of the following parameters: hematocrit, hemoglobin, platelet count or white blood cell count
- Allergies/Hypersensitivity /Pulmonary
- Known hypersensitivity or contraindication to aliskiren or thiazide diuretics.
- History of clinically important malabsorption or gastrointestinal resection.
- Smoking of 10 cigarettes or more is excluded. Also excluded are co-existent conditions which could independently affect the histology of resistance vessels except for diabetes (e.g. any disease which may be associated with vasculitides: collagen-vascular diseases, chronic hepatitis B antigenemia, circulating immune complexes, complement disorders, amyloidosis, scleroderma, etc.).
- Pregnancy or lactating females. Females of childbearing age who are not surgically sterilized and who are using effective contraception may enter only if an exclusionary pregnancy test is done within 72 hours of the first double-blind dose of test agent. Pregnancy tests will then be done monthly throughout the study in women capable of conception.
- Other concurrent severe disease which could preclude participation or survival, such as neoplasm or Acquired Immunodeficiency Syndrome (AIDS), or patients known to be HIV positive.
- Any known bleeding or platelet disorder.
- The known absence of one kidney.
- Patients who are currently abusing or previously abused alcohol or other drug substances (within past two years).
- Mentally or legally incapacitated patients.
- Patients who have participated in another investigational drug trial, including those using marketed drugs (i.e. patient has signed a consent form), within the 28 days prior to start of placebo therapy.
- Patients who, in the opinion of the investigator, will not cooperate fully, keep appointments or are generally unreliable.
- Inability or unwillingness on the part of the patient to sign the Patient Consent Form.
- Phase V of Korotkoff sounds cannot be detected.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cardiovascular Prevention Centre, Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
Official title: A Double-Blind, Randomized, Parallel Design Study of Aliskiren Versus Hydrochlorothiazide in Mild-to Moderate Hypertensive Type II Diabetes Mellitus Patients on Remodeling of Resistance Arteries
This study will be performed only at the Jewish General Hospital. It will investigate the effect of treatment with aliskiren, an inhibitor of renin, a substance produced by the kidney that constricts arteries and raises blood pressure, on the blood vessels, specifically the arteries, of subjects who have diabetes and elevated blood pressure (hypertension).
To investigate blood vessels, different techniques will be used. For large arteries, these will be studied by non invasive methods using detection of the pulse wave or using ultrasound over the skin of the neck, the wrist and the groin. To study small vessels, the investigators will perform a biopsy on the buttock, under local anesthesia, and obtain a small sample of tissue from under the skin, from which the vessels will be dissected. The investigators have performed many hundreds of these small biopsies over the past 20 years for similar studies without any complications. The biopsies are very well tolerated. From this research the investigators will thus be able to learn what the structure and function of these vessels is in these patients, in comparison to a normal healthy group.
Read more
The hypertensive diabetic subjects will then be assigned by chance (randomized trial) to treatment with the renin inhibitor aliskiren or a comparator, the diuretic hydrochlorothiazide. Aliskiren is a relatively new drug used to treat hypertension that is very well tolerated and is now being evaluated in numerous trials in hypertensive diabetic individuals. The diuretic is a well-know agent used to treat high blood pressure now for many years, and which is very well tolerated. Physicians, nurses and scientists involved in the study will be unaware of who is receiving which drug, as will be the patients (this is the meaning of double-blind trial). However, if there is any problem, the secret code will be broken and the individual withdrawn from the study. Subjects will be treated for a year, and the study procedures (non invasive and the biopsy) repeated at 6 months and after one year of treatment. During the study, blood samples will be drawn and urine collected at certain intervals to ensure safety of the treatment.
Once tissues are obtained they will be studied in the laboratory. The study of the vessels will allow treatment us to determine how the treatment with the renin inhibitor aliskiren affects the structure and function as well as cellular and molecular aspects of arteries of hypertensive diabetic persons. The investigators expect these studies to provide us knowledge on mechanisms and perhaps new targets for future therapies of cardiovascular disease and hypertension.
- Conditions
- Hypertension, Diabetes
- Being tested
- Aliskiren vs. hydrochlorothiazide, Hydrochlorothiazide
- Keywords
- resistance arteries, endothelial dysfunction, aortic stiffness
- 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.
Aliskiren vs. hydrochlorothiazideDrug
Also called Aliskiren is Tekturna or Rasilez
Aliskiren will be used at increasing doses from 150 to 300 mg per day for 6-12 months.
HydrochlorothiazideDrug
Also called Hydrochlorothiazide is a generic drug.
Hydrochlorothiazide will be used at increasing doses from 12.5 to 25 mg per day for 6-12 months.
| Study group | Role | What they receive |
|---|---|---|
| Hydrochlorothiazide | Active comparator | Treatment of patients with hydrochlorothiazide and effect on small arteries Receives: Drug: Hydrochlorothiazide |
| Aliskiren | Experimental | Treatment of patients with aliskiren and effect on small arteries Receives: Drug: Aliskiren vs. hydrochlorothiazide; Drug: Hydrochlorothiazide |
| Normotensive non diabetic subjects | No intervention | A comparator non intervention normotensive non diabetic group of healthy subjects will be used for baseline comparison of primary and secondary endpoints |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is baseline-adjusted change in media/lumen ratio in patients who were randomized to aliskiren (group 1) comparatively to those randomized to hydrochlorothiazide (group 2)
The primary endpoint is baseline-adjusted change in media/lumen ratio in patients who were randomized to aliskiren (group 1) comparatively to those randomized to hydrochlorothiazide (group 2)
Measured: 6 months-1 year
Secondary outcomes (3)
Secondary outcome: Pulse wave velocity (PWV) of aorta in hypertensive diabetic patients randomized to aliskiren versus those who were randomized to HCTZ.
Pulse wave velocity (PWV) of aorta in hypertensive diabetic patients randomized to aliskiren versus those who were randomized to HCTZ.
Measured: 6 months-1 year
Augmentation index (AI) of patients randomized to either aliskiren or hydrochlorothiazide
Evaluation by non invasive means with a SphygmoCor of augmentation index (AI) of central aortic blood pressure in response to either aliskiren or hydrochlorothiazide in hypertensive diabetic patients.
Measured: 6 months-1 year
Flow-mediated dilation in hypertensive diabetic patients randomized to aliskiren vs. hydrochlorothiazide
Evaluation by non invasive means with ultrasound of flow-mediated dilation of the brachial artery in response to either aliskiren or hydrochlorothiazide in hypertensive diabetic patients.
Measured: 6 months-1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Because of results of Altitude trial, this trial was cancelled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Ernesto L. Schiffrin, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Ernesto L Schiffrin, MD, PhD, Principal investigator, SMBD-Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480791
- Sponsor's protocol ID
- CSPP100ACA03T
- Status last verified
- May 2015
- First submitted
- 5 Nov 2011
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Schiffrin EL, Park JB, Intengan HD, Touyz RM. Correction of arterial structure and endothelial dysfunction in human essential hypertension by the angiotensin receptor antagonist losartan. Circulation. 2000 Apr 11;101(14):1653-9. doi: 10.1161/01.cir.101.14.1653.
PubMed 10758046Savoia C, Touyz RM, Endemann DH, Pu Q, Ko EA, De Ciuceis C, Schiffrin EL. Angiotensin receptor blocker added to previous antihypertensive agents on arteries of diabetic hypertensive patients. Hypertension. 2006 Aug;48(2):271-7. doi: 10.1161/01.HYP.0000230234.84356.36. Epub 2006 Jun 19.
PubMed 16785331Savoia C, Touyz RM, Amiri F, Schiffrin EL. Selective mineralocorticoid receptor blocker eplerenone reduces resistance artery stiffness in hypertensive patients. Hypertension. 2008 Feb;51(2):432-9. doi: 10.1161/HYPERTENSIONAHA.107.103267. Epub 2008 Jan 14.
PubMed 18195160
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Parallel Design Study of Aliskiren Versus Hydrochlorothiazide in Mild-to Moderate Hypertensive Type II Diabetes Mellitus Patients on Remodeling of Resistance Arteries
- ClinicalTrials.gov ID
- NCT01480791
- Acronym / sponsor ID
- CSPP100ACA03T
- Conditions
- Hypertension, Diabetes
- Keywords
- resistance arteries, endothelial dysfunction, aortic stiffness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because of results of Altitude trial, this trial was cancelled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Nov 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.
This study will be performed only at the Jewish General Hospital. It will investigate the effect of treatment with aliskiren, an inhibitor of renin, a substance produced by the kidney that constricts arteries and raises blood pressure, on the blood vessels, specifically the arteries, of subjects who have diabetes and elevated blood pressure (hypertension).
To investigate blood vessels, different techniques will be used. For large arteries, these will be studied by non invasive methods using detection of the pulse wave or using ultrasound over the skin of the neck, the wrist and the groin. To study small vessels, the investigators will perform a biopsy on the buttock, under local anesthesia, and obtain a small sample of tissue from under the skin, from which the vessels will be dissected. The investigators have performed many hundreds of these small biopsies over the past 20 years for similar studies without any complications. The biopsies are very well tolerated. From this research the investigators will thus be able to learn what the structure and function of these vessels is in these patients, in comparison to a normal healthy group.
The hypertensive diabetic subjects will then be assigned by chance (randomized trial) to treatment with the renin inhibitor aliskiren or a comparator, the diuretic hydrochlorothiazide. Aliskiren is a relatively new drug used to treat hypertension that is very well tolerated and is now being evaluated in numerous trials in hypertensive diabetic individuals. The diuretic is a well-know agent used to treat high blood pressure now for many years, and which is very well tolerated. Physicians, nurses and scientists involved in the study will be unaware of who is receiving which drug, as will be the patients (this is the meaning of double-blind trial). However, if there is any problem, the secret code will be broken and the individual withdrawn from the study. Subjects will be treated for a year, and the study procedures (non invasive and the biopsy) repeated at 6 months and after one year of treatment. During the study, blood samples will be drawn and urine collected at certain intervals to ensure safety of the treatment.
Once tissues are obtained they will be studied in the laboratory. The study of the vessels will allow treatment us to determine how the treatment with the renin inhibitor aliskiren affects the structure and function as well as cellular and molecular aspects of arteries of hypertensive diabetic persons. The investigators expect these studies to provide us knowledge on mechanisms and perhaps new targets for future therapies of cardiovascular disease and hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydrochlorothiazide | Active comparator | Drug: HydrochlorothiazideTreatment of patients with hydrochlorothiazide and effect on small arteries |
| Aliskiren | Experimental | Drug: Aliskiren vs. hydrochlorothiazide, Drug: HydrochlorothiazideTreatment of patients with aliskiren and effect on small arteries |
| Normotensive non diabetic subjects | No intervention | –A comparator non intervention normotensive non diabetic group of healthy subjects will be used for baseline comparison of primary and secondary endpoints |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Hypertensive Group
- Diabetes mellitus (diagnosed for at least 6 months) will be defined by usual criteria based on basal glycemia or glucose tolerance test . Diabetes must be well controlled, with glycosylated hemoglobin below 0.08 (8%).
- Hypertension is defined as a mean SiSBP > 130 mmHg or SiDBP of 85-115mmHg at the screening visit, and after two weeks of placebo therapy. (Hypertension will be considered essential if there is no evidence of an underlying treatable cause after suitable clinical and laboratory assessment. Hypertensive patients may be taking any antihypertensive agent except a renin inhibitor. They may be taking an ACE inhibitor or an ARB, which will not be discontinued. If they have been on HCTZ, they are eligible to participate.
- Subjects are 30-70 years old
- Informed Consent obtained by patient
Key exclusion criteria (42 listed)
- Uncontrolled diabetes ( defined as: preprandial glycemia usually above 10 mmol/L and glycosylated hemoglobin above 0.08).
- Renovascular hypertension
- History of malignant hypertension
- Sitting systolic blood pressure > 210 mmHg
- Cerebrovascular accident within the past year, or current transient ischemic attacks
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 |
|---|---|---|
| Aliskiren vs. hydrochlorothiazideAlso: Aliskiren is Tekturna or RasilezAliskiren will be used at increasing doses from 150 to 300 mg per day for 6-12 months. | Drug | Aliskiren |
| HydrochlorothiazideAlso: Hydrochlorothiazide is a generic drug.Hydrochlorothiazide will be used at increasing doses from 12.5 to 25 mg per day for 6-12 months. | Drug | Aliskiren, Hydrochlorothiazide |
Primary outcome
The primary endpoint is baseline-adjusted change in media/lumen ratio in patients who were randomized to aliskiren (group 1) comparatively to those randomized to hydrochlorothiazide (group 2)
Time frame: 6 months-1 year
The primary endpoint is baseline-adjusted change in media/lumen ratio in patients who were randomized to aliskiren (group 1) comparatively to those randomized to hydrochlorothiazide (group 2)
3 secondary outcomes
Secondary outcome: Pulse wave velocity (PWV) of aorta in hypertensive diabetic patients randomized to aliskiren versus those who were randomized to HCTZ.
Time frame: 6 months-1 year
Augmentation index (AI) of patients randomized to either aliskiren or hydrochlorothiazide
Time frame: 6 months-1 year
Flow-mediated dilation in hypertensive diabetic patients randomized to aliskiren vs. hydrochlorothiazide
Time frame: 6 months-1 year
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 19 May 2015.
- Background: PubMed 10758046Schiffrin EL, Park JB, Intengan HD, Touyz RM. Correction of arterial structure and endothelial dysfunction in human essential hypertension by the angiotensin receptor antagonist losartan. Circulation. 2000 Apr 11;101(14):1653-9. doi: 10.1161/01.cir.101.14.1653.
- Background: PubMed 16785331Savoia C, Touyz RM, Endemann DH, Pu Q, Ko EA, De Ciuceis C, Schiffrin EL. Angiotensin receptor blocker added to previous antihypertensive agents on arteries of diabetic hypertensive patients. Hypertension. 2006 Aug;48(2):271-7. doi: 10.1161/01.HYP.0000230234.84356.36. Epub 2006 Jun 19.
- Background: PubMed 18195160Savoia C, Touyz RM, Amiri F, Schiffrin EL. Selective mineralocorticoid receptor blocker eplerenone reduces resistance artery stiffness in hypertensive patients. Hypertension. 2008 Feb;51(2):432-9. doi: 10.1161/HYPERTENSIONAHA.107.103267. Epub 2008 Jan 14.
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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.
Ernesto L Schiffrin, MD, PhD principal investigator
SMBD-Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aliskiren vs. hydrochlorothiazide and Hydrochlorothiazide in people with Hypertension and Diabetes, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
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 10 inclusion and 42 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 19 May 2015. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary endpoint is baseline-adjusted change in media/lumen ratio in patients who were randomized to aliskiren (group 1) comparatively to those randomized to hydrochlorothiazide (group 2) (time frame: 6 months-1 year). 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 NCT01480791, which also lists 3 linked publications.
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 19 May 2015.