Diabetes Type 2Phase 3DIABASINCT00984750
Acetyl-L-Carnitine in Type 2 Diabetes
A Phase 3 study testing acetyl-L-carnitine/statin (simvastatin) in people with Diabetes Type 2 and Hypertension, run by Mario Negri Institute for Pharmacological Research at 5 sites in Italy.
Trial summary
Decreased insulin sensitivity (or insulin resistance) is a major risk factor for type 2 diabetes mellitus and renal and cardiovascular disease. It is the key component and, possibly, a pathogenetic factor of the metabolic syndrome - a clustering of arterial hypertension, obesity, impaired glucose tolerance… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Diabetes Type 2, Hypertension
- What is being tested?
- acetyl-L-carnitine/statin (simvastatin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 229 participants
- Where
- 5 sitesItaly
- Study dates
- Apr 2008to Dec 2012
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females >40 years old;
- High-risk subjects with type 2 diabetes (WHO criteria);
- High blood pressure (systolic blood pressure >140 mmHg or with concomitant antihypertensive treatment stable since at least 3 months);
- Serum creatinine concentration <1.5 mg/dl;
- Patients legally able to give written informed consent to the trial (signed and dated by the patient);
- Written informed consent.
Who cannot join
- Uncontrolled diabetes (glycated hemoglobin >11%);
- Acute cardiovascular events over the last 3 months;
- Specific contraindications or history of hypersensitivity to the study drugs;
- Previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer;
- Drug or alcohol abuse;
- Any chronic clinical conditions that may affect completion of the trial or confound data interpretation;
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- Pregnancy or lactating;
- Women of childbearing potential without following a scientifically accepted form of contraception;
- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial;
- Evidence of an uncooperative attitude;
- Any evidence that patient will not be able to complete the trial follow-up.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Hospital "Azienda Ospedaliera Ospedali Riunitidi Bergamo" Unit of Diabetology
Bergamo, Bergamo, 24100
Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" Ambulatory of Diabetology
Ponte San Pietro, Bergamo, 24036
Clinical Research Center for Rare Diseases "Aldo and Cele Daccò"
Ranica, Bergamo, 24020
Hospital "Azienda Ospedaliera di Treviglio-Caravaggio"Unit of Diabetology and Metabolic Diseases
Romano di Lombardia, Bergamo
Hospital "Azienda Ospedaliera di Treviglio-Caravaggio" Unit of Diabetology and Metabolic Disease
Treviglio, Bergamo
About this study
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effect of 6-month Acetylcarnitine Therapy on Arterial Blood Pressure, Lipid and Metabolic Profile, and Kidney Function in Hypertensive Patients With Type 2 Diabetes on Background Simvastatin Therapy
Decreased insulin sensitivity (or insulin resistance) is a major risk factor for type 2 diabetes mellitus and renal and cardiovascular disease. It is the key component and, possibly, a pathogenetic factor of the metabolic syndrome - a clustering of arterial hypertension, obesity, impaired glucose tolerance, dyslipidemia, coagulation abnormalities, albuminuria and increased cardiovascular risk - that may precede or accompany type 2 diabetes.
Insulin function and the abnormalities associated with insulin resistance, may have a major role in preventing type 2 diabetes and, in the long-term, diabetes micro- and macrovascular complications. Carnitine is involved in lipids and carbohydrates metabolism and acetyl-L-carnitine (ALC), an intramitochondrial carrier of acylic group, may modulate cell fuel substrate utilization. Studies found that carnitine may improve insulin sensitivity and glucose disposal in healthy subjects and in patients with type 2 diabetes. A recent study found that a primed constant infusion of acetyl-L-carnitine (ALC) may increase glucose utilization in type 2 diabetic patients, possibly restoring the glycogen synthase activity.
Read more
In a previous pilot study in healthy subjects with decreased insulin sensitivity, the investigators found that 6-month treatment with Acetyl-L-Carnitine - an ester of l-carnitine - improved the glucose disposal rate, taken as a marker of insulin sensitivity. Amelioration of insulin sensitivity was associated with a significant and clinically relevant reduction in systolic blood pressure without appreciable changes in diastolic blood pressure. Whether blood pressure reduction reflected the amelioration of insulin sensitivity or, rather, a direct, specific effect of Acetyl-L-Carnitine is still unknown.The antihypertensive effect ensued progressively and slowly waned after treatment withdrawal as documented by a slow and progressive increase in blood pressure levels toward baseline levels over the recovery period. This finding provided convincing evidence that blood pressure reduction throughout the observation period was not explained by a "trial effect", but reflected a true treatment effect. Blood pressure was a secondary efficacy variable of the study and mechanisms underlying the antihypertensive effect of Acetyl-L-Carnitine (such as reduced peripheral resistances, decreased cardiac output, increased artery compliance and/or enhanced sodium excretion), in this population were not assessed.
Acetyl-L-Carnitine was well tolerated in all of the patients and may provide a novel therapeutic tool for the treatment of arterial hypertension, and of dyslipidemia and could be safely used in people with type 2 diabetes.
Thus, the investigators designed a prospective, randomized, double-blind, placebo-controlled trial to investigate whether Acetyl-L-Carnitine added-on stable and standardized blood pressure and lipid lowering therapy may help further improving control of hypertension and dyslipidemia and, therefore, decreasing the overall cardiovascular risk in hypertensive patients with type 2 diabetes.
Read the detailed description
BACKGROUND Arterial hypertension, in particular systolic hypertension, is a common component of the metabolic syndrome, a syndrome of hypertension, abdominal obesity, dyslipidemia, impaired glucose tolerance and increased urinary albumin excretion sustained by decreased tissue sensitivity to insulin (insulin resistance). It affects 80 to 90% of people with type 2 diabetes and is the strongest risk factor for macrovascular and microvascular complications of diabetes, such as myocardial infarction, stroke, peripheral artery disease, nephropathy and retinopathy. Despite multi-drug therapy, reduction of systolic blood pressure to normal range is seldom achievable in people with type 2 diabetes. Moreover, due to increased vascular stiffness, reducing systolic blood pressure may decrease diastolic blood pressure to the extent that diastolic myocardial perfusion is impaired and the risk of ischemic event increased. Thus, availability of drugs that may help controlling systolic hypertension without appreciably affecting diastolic blood pressure would have major clinical implications.
In addition to arterial hypertension, dyslipidemia is also a component of the metabolic syndrome that is almost invariably observed in people with type 2 diabetes and remarkably contributes to the excess cardiovascular risk in this population. HMGCoA inhibition by statin therapy, significantly ameliorates hypercholesterolemia, but only marginally affects the concomitant hypertriglyceridemia (probably the most typical feature of increased insulin resistance) and fails to significantly reduce the circulating levels of serum lipoprotein(a), one of the strongest predictors of coronary and cerebrovascular events in type 2 diabetics. Thus, availability of drugs that may help achieving a more effective amelioration of dyslipidemia in this population might also have important clinical implications .
In an ongoing study in healthy subjects with decreased insulin sensitivity, we found that 6-month treatment with acetylcarnitine - an ester of l-carnitine - improved the glucose disposal rate, taken as a marker of insulin sensitivity. Amelioration of insulin sensitivity was associated with a significant and clinically relevant reduction in systolic blood pressure without appreciable changes in diastolic blood pressure. Whether blood pressure reduction reflected the amelioration of insulin sensitivity or, rather, a direct, specific effect of acetylcarnitine is still unknown.
Previous studies also found that L-carnitine added on background simvastatin therapy, marginally affected serum cholesterol, but remarkably reduced serum triglyceride and lipoprotein (a) levels. Whether amelioration of insulin resistance may explain at least in part this effect is unclear.
Finally, all available clinical studies consistently showed that acetyl carnitine is a well tolerated drug that can be safely used in humans. Experimental evidence is also available that l-carnitine may improve statin-associated myotoxicity.
AIMS Primary To asses the effect of 6-month therapy with acetylcarnitine compared to placebo on systolic blood pressure in 228 patients with type 2 diabetes, arterial hypertension and dyslipidemia on stable background antihypertensive, hypoglycemic, and lipid lowering therapy.
Secondary
A.To asses the effect of treatment on:
- diastolic and pulse pressure
- serum triglycerides and apolipoprotein(a)
- HOMA index (calculated during data analyses), serum insulin, leptin, adiponectin (pending on the findings on the other efficacy variables)
- blood glucose, serum cholesterol (total, HDL and LDL), non-esterified fatty acids (NEFA), lipoproteins A and and uric acid
- 2-hours post oral load blood glucose profile
- high density C-reactive protein (hsCRP)
- urinary albumin excretion and estimated creatinine clearance (calculated during data analyses)
- cardiac output, peripheral resistances or large artery compliance (as assessed by echocardiography in a representative subgroup)
- 24 hour sodium excretion and sodium fractional clearance, in a representative subgroup
- need for concomitant therapy with antihypertensive, hypoglycemic, and lipid lowering agents
B.To assess whether the observed changes in systolic, diastolic or pulse pressures and in lipid or metabolic profile correlate with the concomitant changes in markers of insulin sensitivity.
C.To monitor systolic/diastolic blood pressure and other clinical/laboratory parameters evaluated during the study two months after Acetyl-L-Carnitine therapy or Placebo withdrawal in patients completing the study and maintained on the same background medications.
DESIGN The study will be a prospective, randomized, double-blind, placebo-controlled, multicenter trial.
- Conditions
- Diabetes Type 2, Hypertension
- Being tested
- acetyl-L-carnitine/statin (simvastatin), placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetyl-L-carnitine/statin (simvastatin)Drug
acetyl-L-carnitine: 4 tablets of 500 mg a day
simvastatin: 10 to 20 mg/day as deemed clinically appropriate and according to tolerability
placeboDrug
placebo: 4 tablets of 500 mg a day simvastatin: 10 to 20 mg/day as deemed clinically appropriate and according to tolerability
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Statin and acetyl-L-carnitine Receives: Drug: acetyl-L-carnitine/statin (simvastatin) |
| 2 | Placebo comparator | Statin and placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood pressure and dyslipidemia
Measured: Basal, 15th day, 30th day, 3rd and 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startApr 2008
- Primary completionMay 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Sponsor type
- University, hospital or other
- Collaborators
- Leadiant Biosciences, Inc.
- Responsible party
- Sponsor
- Investigators
- Piero Ruggenenti, MD, Study director, Mario Negri Institute for Pharmacological Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984750
- Sponsor's protocol ID
- DIABASI
- Other IDs
- 2007-005925-31
- Acronym
- DIABASI
- Status last verified
- Feb 2013
- First submitted
- 23 Sep 2009
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effect of 6-month Acetylcarnitine Therapy on Arterial Blood Pressure, Lipid and Metabolic Profile, and Kidney Function in Hypertensive Patients With Type 2 Diabetes on Background Simvastatin Therapy
- ClinicalTrials.gov ID
- NCT00984750
- Acronym / sponsor ID
- DIABASI / DIABASI
- Conditions
- Diabetes Type 2, Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Leadiant Biosciences, Inc.
- Study start
- Apr 2008
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Sep 2009 (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.
Decreased insulin sensitivity (or insulin resistance) is a major risk factor for type 2 diabetes mellitus and renal and cardiovascular disease. It is the key component and, possibly, a pathogenetic factor of the metabolic syndrome - a clustering of arterial hypertension, obesity, impaired glucose tolerance, dyslipidemia, coagulation abnormalities, albuminuria and increased cardiovascular risk - that may precede or accompany type 2 diabetes.
Insulin function and the abnormalities associated with insulin resistance, may have a major role in preventing type 2 diabetes and, in the long-term, diabetes micro- and macrovascular complications. Carnitine is involved in lipids and carbohydrates metabolism and acetyl-L-carnitine (ALC), an intramitochondrial carrier of acylic group, may modulate cell fuel substrate utilization. Studies found that carnitine may improve insulin sensitivity and glucose disposal in healthy subjects and in patients with type 2 diabetes. A recent study found that a primed constant infusion of acetyl-L-carnitine (ALC) may increase glucose utilization in type 2 diabetic patients, possibly restoring the glycogen synthase activity.
In a previous pilot study in healthy subjects with decreased insulin sensitivity, the investigators found that 6-month treatment with Acetyl-L-Carnitine - an ester of l-carnitine - improved the glucose disposal rate, taken as a marker of insulin sensitivity. Amelioration of insulin sensitivity was associated with a significant and clinically relevant reduction in systolic blood pressure without appreciable changes in diastolic blood pressure. Whether blood pressure reduction reflected the amelioration of insulin sensitivity or, rather, a direct, specific effect of Acetyl-L-Carnitine is still unknown.The antihypertensive effect ensued progressively and slowly waned after treatment withdrawal as documented by a slow and progressive increase in blood pressure levels toward baseline levels over the recovery period. This finding provided convincing evidence that blood pressure reduction throughout the observation period was not explained by a "trial effect", but reflected a true treatment effect. Blood pressure was a secondary efficacy variable of the study and mechanisms underlying the antihypertensive effect of Acetyl-L-Carnitine (such as reduced peripheral resistances, decreased cardiac output, increased artery compliance and/or enhanced sodium excretion), in this population were not assessed.
Acetyl-L-Carnitine was well tolerated in all of the patients and may provide a novel therapeutic tool for the treatment of arterial hypertension, and of dyslipidemia and could be safely used in people with type 2 diabetes.
Thus, the investigators designed a prospective, randomized, double-blind, placebo-controlled trial to investigate whether Acetyl-L-Carnitine added-on stable and standardized blood pressure and lipid lowering therapy may help further improving control of hypertension and dyslipidemia and, therefore, decreasing the overall cardiovascular risk in hypertensive patients with type 2 diabetes.
Detailed description
BACKGROUND Arterial hypertension, in particular systolic hypertension, is a common component of the metabolic syndrome, a syndrome of hypertension, abdominal obesity, dyslipidemia, impaired glucose tolerance and increased urinary albumin excretion sustained by decreased tissue sensitivity to insulin (insulin resistance). It affects 80 to 90% of people with type 2 diabetes and is the strongest risk factor for macrovascular and microvascular complications of diabetes, such as myocardial infarction, stroke, peripheral artery disease, nephropathy and retinopathy. Despite multi-drug therapy, reduction of systolic blood pressure to normal range is seldom achievable in people with type 2 diabetes. Moreover, due to increased vascular stiffness, reducing systolic blood pressure may decrease diastolic blood pressure to the extent that diastolic myocardial perfusion is impaired and the risk of ischemic event increased. Thus, availability of drugs that may help controlling systolic hypertension without appreciably affecting diastolic blood pressure would have major clinical implications.
In addition to arterial hypertension, dyslipidemia is also a component of the metabolic syndrome that is almost invariably observed in people with type 2 diabetes and remarkably contributes to the excess cardiovascular risk in this population. HMGCoA inhibition by statin therapy, significantly ameliorates hypercholesterolemia, but only marginally affects the concomitant hypertriglyceridemia (probably the most typical feature of increased insulin resistance) and fails to significantly reduce the circulating levels of serum lipoprotein(a), one of the strongest predictors of coronary and cerebrovascular events in type 2 diabetics. Thus, availability of drugs that may help achieving a more effective amelioration of dyslipidemia in this population might also have important clinical implications .
In an ongoing study in healthy subjects with decreased insulin sensitivity, we found that 6-month treatment with acetylcarnitine - an ester of l-carnitine - improved the glucose disposal rate, taken as a marker of insulin sensitivity. Amelioration of insulin sensitivity was associated with a significant and clinically relevant reduction in systolic blood pressure without appreciable changes in diastolic blood pressure. Whether blood pressure reduction reflected the amelioration of insulin sensitivity or, rather, a direct, specific effect of acetylcarnitine is still unknown.
Previous studies also found that L-carnitine added on background simvastatin therapy, marginally affected serum cholesterol, but remarkably reduced serum triglyceride and lipoprotein (a) levels. Whether amelioration of insulin resistance may explain at least in part this effect is unclear.
Finally, all available clinical studies consistently showed that acetyl carnitine is a well tolerated drug that can be safely used in humans. Experimental evidence is also available that l-carnitine may improve statin-associated myotoxicity.
AIMS Primary To asses the effect of 6-month therapy with acetylcarnitine compared to placebo on systolic blood pressure in 228 patients with type 2 diabetes, arterial hypertension and dyslipidemia on stable background antihypertensive, hypoglycemic, and lipid lowering therapy.
Secondary
A.To asses the effect of treatment on:
- diastolic and pulse pressure
- serum triglycerides and apolipoprotein(a)
- HOMA index (calculated during data analyses), serum insulin, leptin, adiponectin (pending on the findings on the other efficacy variables)
- blood glucose, serum cholesterol (total, HDL and LDL), non-esterified fatty acids (NEFA), lipoproteins A and and uric acid
- 2-hours post oral load blood glucose profile
- high density C-reactive protein (hsCRP)
- urinary albumin excretion and estimated creatinine clearance (calculated during data analyses)
- cardiac output, peripheral resistances or large artery compliance (as assessed by echocardiography in a representative subgroup)
- 24 hour sodium excretion and sodium fractional clearance, in a representative subgroup
- need for concomitant therapy with antihypertensive, hypoglycemic, and lipid lowering agents
B.To assess whether the observed changes in systolic, diastolic or pulse pressures and in lipid or metabolic profile correlate with the concomitant changes in markers of insulin sensitivity.
C.To monitor systolic/diastolic blood pressure and other clinical/laboratory parameters evaluated during the study two months after Acetyl-L-Carnitine therapy or Placebo withdrawal in patients completing the study and maintained on the same background medications.
DESIGN The study will be a prospective, randomized, double-blind, placebo-controlled, multicenter trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: acetyl-L-carnitine/statin (simvastatin)Statin and acetyl-L-carnitine |
| 2 | Placebo comparator | Drug: placeboStatin and placebo |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females >40 years old;
- High-risk subjects with type 2 diabetes (WHO criteria);
- High blood pressure (systolic blood pressure >140 mmHg or with concomitant antihypertensive treatment stable since at least 3 months);
- Serum creatinine concentration <1.5 mg/dl;
- Patients legally able to give written informed consent to the trial (signed and dated by the patient);
Key exclusion criteria (11 listed)
- Uncontrolled diabetes (glycated hemoglobin >11%);
- Acute cardiovascular events over the last 3 months;
- Specific contraindications or history of hypersensitivity to the study drugs;
- Previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer;
- Drug or alcohol abuse;
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 |
|---|---|---|
| acetyl-L-carnitine/statin (simvastatin)acetyl-L-carnitine: 4 tablets of 500 mg a day simvastatin: 10 to 20 mg/day as deemed clinically appropriate and according to tolerability | Drug | 1 |
| placeboplacebo: 4 tablets of 500 mg a day simvastatin: 10 to 20 mg/day as deemed clinically appropriate and according to tolerability | Drug | 2 |
Primary outcome
Arterial blood pressure and dyslipidemia
Time frame: Basal, 15th day, 30th day, 3rd and 6th month
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 25 Feb 2013.
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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.
Piero Ruggenenti, MD study director
Mario Negri Institute for Pharmacological Research
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acetyl-L-carnitine/statin (simvastatin) in people with Diabetes Type 2 and Hypertension, run by Mario Negri Institute for Pharmacological Research at 5 sites in Italy.
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 11 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 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Arterial blood pressure and dyslipidemia (time frame: Basal, 15th day, 30th day, 3rd and 6th month). 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 25 Feb 2013; AzTrials last refreshed its copy on 1 Nov 2026.