DyslipidemiaPhase 2CENTAURNCT00728910
Combined Effects of Non-statin Treatments on Apolipoprotein A-I Up-Regulation (CENTAUR): A Feasibility Study
A Phase 2 study testing Atorvastatin, ABT335 and ER Niacin in people with Dyslipidemia, run by University of Pennsylvania at 1 site in United States.
Trial summary
The investigators propose to investigate if using a combination of medications that may improve cholesterol give additional benefit to that gained from the statin medication, Lipitor. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Atorvastatin, ABT335 and ER Niacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Aug 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men/women aged 18-80 years.
- Low HDL-C, adjusted for baseline statin use
- Not on statin: Men with HDL <= 40 or women with HDL <= 50 mg/dL
- On statin: Men with HDL <= 42 or women with HDL <= 52 mg/dL
- TG/HDL ratio >= 3.5
- Able to understand and agree to informed consent
- Women of child-bearing age must test negative on a urine pregnancy test and agree to use reliable birth control during the study and for 1 month after last dose of study drugs. Reliable methods include oral contraceptives, a barrier method, intrauterine device, partner with vasectomy, or abstinence.
- Willing to be available for study duration and follow study procedures
Who cannot join
- Subjects with following lipoprotein disorders:
- Patients on high-potency lipid-lowering regimen, defined as two or more prescription lipid-altering medications (excluding fish oils) where one is a high-dose statin (40 mg/day of rosuvastatin, 80 mg/day of other approved statins). Those on combination therapy with a lower statin dose or those taking high-dose statin monotherapy (excluding fish oils) may participate. Patients will switch to atorvastatin 10 mg and/or wash off other lipid medications to participate
- LDL > 190 mg/dL
- TG > 750 mg/dL or pancreatitis from triglyceridemia, regardless of current TG levels
- Dysbetalipoproteinemia (VLDL/TG > 0.3 -AND- TG > 200 mg/dL).
- Use of non-statin lipid therapy prior to study initiation is exclusionary if (n.b. washout of non-statins is permitted):
Show all 38Show fewer
- Niacin > 250 mg/ day within 6 weeks: Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, or supplemental niacin
- Fibrates within 12 weeks: fenofibrate (Antara, Lofibra, Tricor, Triglide), gemfibrozil (Lopid), or clofibrate
- Enterically active drugs within 4 weeks: colestipol, cholestyramine, colesevelam, ezetimibe, orlistat.
- Red yeast rice during the treatment phase of the study (i.e. must be switched to study statin)
- Fish oil > 2 g/day within 4 weeks: Lovaza (née Omacor), numerous supplements
- Altered dose of a selective estrogen receptor modulator (SERM) within 4 weeks
- Intolerance to statin, fibrate, aspirin, deuterated leucine, or niacin
- Contraindications to medications, including chronic muscle disease, history of rhabdomyolysis, moderate-severe gout, severe peptic ulcer disease, bleeding disorders, and aspirin-sensitive asthma.
- Diabetics, or fasting glucose > 110 mg/dL on two different days during screening, or use of anti-diabetic medications within 6 weeks of screening visit
- Chronic renal insufficiency, nephrotic syndrome, or current serum creatinine > 2.5 mg/dL, or GFR < 60 mL/min/1.73m2 by the MDRD equation.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin > 2 X the upper limit of normal (ULN), albumin of < 2.5 mg/dL, prothrombin time (PT) > 1.5 X ULN, partial thromboplastin time (PTT) > 1.5 X ULN, or current active hepatobiliary disease
- Hemoglobin (Hgb) < 10 mg/dL
- Weight < 110 lbs
- Use of an investigational drug within 6 weeks prior to screening visit
- Major surgery within the previous 6 weeks, or anticipated major surgery during course of study, or any history of organ transplant
- Non-skin malignancy within previous 5 years
- Drug abuse within past 3 years, or regular alcohol use >14 drinks/week
- Women who are pregnant, plan to conceive, or breast-feed
- Any serious or unstable medical or psychological conditions that, in investigator's opinion would compromise subject safety or successful participation.
- Currently adhering to, planning to adhere to or used within 3 months prior to screening, supplements intended for weight loss or adopt diets with aggressive carbohydrate restrictions, such as but not limited to Atkins or South Beach diets.
- Currently taking Vitamin A supplements (multivitamins allowed)(washout permitted)
- Excluded concomitant medications
- Immunosuppressants within 2 months prior to screening or are likely to require such treatment during the course of the study
- Warfarin.
- Disinclination to dairy products (e.g. inviolable dietary restrictions or lactose intolerance to an 8oz glass of milk despite lactase supplementation) Lactase supplementation is allowed during the study.
- Regular consumers of grapefruit juice, or currently taking medications metabolized by CYP 3A4 (cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone)
- History of pancreatitis or gallbladder disease
- History of coronary heart disease
- History of intolerance/adverse reaction to heparin or women who have dysfunctional uterine bleeding
- Thrombocytopenia at screening
- History of intracerebral or significant GI bleed
- Subjects doing regular strenuous activity or have a CK > 3x ULN at screening
Trial locations and contacts
1 site in 1 country.
United States1 site
CTRC (Clinical Translational Research Center)
Philadelphia, Pennsylvania, 19104
About this study
The investigators propose to investigate if using a combination of medications that may improve cholesterol give additional benefit to that gained from the statin medication, Lipitor. It is recommended that patients who meet certain criteria for risk of heart disease take a statin medication to improve cholesterol and hopefully reduce risk of heart disease. The combination therapy will include Lipitor, Niaspan, and investigational medication (known as ABT335) in a class of drugs called fibrates. We are looking to see if and how these three medications together might improve risk factors for atherosclerosis and influence HDL cholesterol. The study will also look at the safety and any side effects that might be associated with this combination of medications.
Read the detailed description
Objectives Summary
- To investigate whether the progressive addition of a fibrate and niacin to baseline statin therapy will improve apolipoprotein A-I kinetics, postprandial lipidemia, and postabsorptive lipoproteins and metabolism in adult men and women with atherogenic dyslipidemia.
Major Efficacy Aims
- Objective 1 is to test the hypothesis that the fibrate ABT335 and extended release (ER) niacin progressively improve apolipoprotein A-I kinetics when added sequentially to baseline therapy with atorvastatin. The key outcomes include the apolipoprotein AI rate of catabolism and rate of production.
- Objective 2 is to test the hypothesis that the fibrate ABT335 and ER niacin progressively improve postprandial lipidemia by oral fat challenge when added sequentially to baseline therapy with atorvastatin. Key outcomes include the incremental area under the curve for triglycerides and high-density lipoprotein cholesterol.
- Objective 3 is to test the hypothesis that the fibrate ABT335 and ER niacin progressively improve markers of postabsorptive lipoproteins and metabolism when added sequentially to baseline therapy with atorvastatin. Key outcomes include a. fasting cholesterol efflux, b. HDL cholesterol, apolipoprotein A-I, and enzymes that remodel HDL, c. atherogenic lipoproteins, and d. markers of energy metabolism and e. markers of inflammation.
Additional Aims
- Objective 4 is to assess tolerability and adverse events when ABT335 and ER niacin are added sequentially to atorvastatin. Specifically, we will assess changes in hepatobiliary laboratory tests (including incidence of elevation), incidence of symptomatic myalgia, and incidence of flushing. On an exploratory basis, we will enhance the flushing evaluation with objective and subjective measurements of flushing during inpatient visits.
Study Design:
This is an open-label feasibility study of fixed-sequence addition of lipid-altering medications, in which comparisons are made to the baseline for each subject. Subjects begin a lead-in phase in which they start the study statin (atorvastatin) or switch from previous statin therapy to the study statin. Subjects will wash off other excluded lipid-altering drugs during the lead-in. Subjects return for the first inpatient visit, where they have baseline studies on statin monotherapy. At the end of this visit, subjects are started on fibrate therapy (ABT335). They repeat the studies on dual therapy with statin and fibrate, and then add niacin (ER niacin). To minimize flushing during chronic treatment, they start aspirin 325 mg daily, or titrate to 325 mg if they are taking a lower dose of aspirin (e.g. 81 mg). Finally, they repeat the studies on triple therapy with statin, fibrate, and niacin/aspirin.
- Conditions
- Dyslipidemia
- Being tested
- Atorvastatin, ABT335, ER Niacin
- Keywords
- Low HDL cholesterol, High triglycerides, niacin, fibrate
- Medical subject headings
- Dyslipidemias, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
10 mg QD for 4 weeks
ABT335Drug
Also called Trilipex
135 mg QD added to atorvastatin for 8 weeks
ER NiacinDrug
Also called Niaspan
2000 mg QD added to atorvastatin and ABT335 for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Active comparator | atorvastatin 10 mg/day by mouth for a total duration of 4 weeks Receives: Drug: Atorvastatin |
| ABT335 | Active comparator | ABT335 135 mg/day by mouth added to atorvastatin for a total duration of at least 8 Receives: Drug: Atorvastatin; Drug: ABT335 |
| ER niacin | Active comparator | ER niacin titrated up to 2 g/day with aspirin 325 mg/day by mouth added to atorvastatin and ABT335 for 10 weeks Receives: Drug: Atorvastatin; Drug: ABT335; Drug: ER Niacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Apolipoprotein A-I Fractional Catabolic Rate (FCR)
After receiving total daily caloric intake over 20 hrs as 20 identical small meals, starting at 0600 hrs, subjects took study medications at 0800 hrs. Five hours after the first meal, i.v. 5,5,5-2H3-L-leucine was administered, followed by a primed-constant infusion at 10 mol/kg body weight per hr for 15 hrs during which 14 blood samples were collected. Isotopic enrichment of leucine in apoA1 band excised from polyacrylamide gel was calculated. Assuming steady state apo A-I metabolism, we used a compartment model to fit data, consisting a precursor compartment (Compartment 1), the plasma leucine pool, an intracellular compartment accounting for apoA1 synthesis and lipoprotein assembly (Compartment 2), and compartments to account for dispositional kinetics of the subfractions including a plasma pool compartment (Compartment 3). The apoA1 FCR corresponds to the rate of irreversible loss of leucine pools from Compartment 3.
Measured: 4 weeks, 12 weeks and 22 weeks
Apo-A1 Production Rate
The apolipoprotein A-I production rate using (5,5,5-2H3-L-leucine) was measured following each of the three study periods i.e following 4 weeks of atorvastatin 10 mg/day, following 8 further weeks of ABT335 135 mg/day added to atorvastatin and following 10 further weeks of ER niacin 2000 mg/day and aspirin 325 mg/day added to atorvastatin+ABT335.
Measured: 4 weeks, 12 weeks and 22 weeks
Post-prandial Triglyceride Incremental Area Under the Curve (iAUC)
Triglyceride iAUC was measured during an oral fat tolerance test administered after 4 weeks of atorvastatin 10 mg/day , a further 8 weeks of atorvastatin 10mg /day+ABT335 135mg/day and then after a further 10 weeks of atorvastatin 10 mg/day+ABT335 135 mg/day+Niaspan 2000 mg/day. The standardized oral fat load was administered one hour post medication dosing and blood was collected prior to drug dosing, prior to the oral fat load and hourly thereafter for 10 hours (0,1,2,3,4,5,6,7,8,9,10,12 hrs post drug dosing)
Measured: 4 weeks, 12 weeks, 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Richard Dunbar, University of Pennsylvania
- Investigators
- Richard L Dunbar, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728910
- Sponsor's protocol ID
- 807965 CNTR
- Other IDs
- CTRC #1123
- Acronym
- CENTAUR
- Status last verified
- Jan 2016
- First submitted
- 4 Aug 2008
- Last updated
- 29 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Non-statin Treatments on Apolipoprotein A-I Up-Regulation (CENTAUR): A Feasibility Study
- ClinicalTrials.gov ID
- NCT00728910
- Acronym / sponsor ID
- CENTAUR / 807965 CNTR
- Conditions
- Dyslipidemia
- Keywords
- Low HDL cholesterol, High triglycerides, niacin, fibrate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jun 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 6 Aug 2008 (estimated)
- Results
- Posted 29 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to investigate if using a combination of medications that may improve cholesterol give additional benefit to that gained from the statin medication, Lipitor. It is recommended that patients who meet certain criteria for risk of heart disease take a statin medication to improve cholesterol and hopefully reduce risk of heart disease. The combination therapy will include Lipitor, Niaspan, and investigational medication (known as ABT335) in a class of drugs called fibrates. We are looking to see if and how these three medications together might improve risk factors for atherosclerosis and influence HDL cholesterol. The study will also look at the safety and any side effects that might be associated with this combination of medications.
Detailed description
Objectives Summary
- To investigate whether the progressive addition of a fibrate and niacin to baseline statin therapy will improve apolipoprotein A-I kinetics, postprandial lipidemia, and postabsorptive lipoproteins and metabolism in adult men and women with atherogenic dyslipidemia.
Major Efficacy Aims
- Objective 1 is to test the hypothesis that the fibrate ABT335 and extended release (ER) niacin progressively improve apolipoprotein A-I kinetics when added sequentially to baseline therapy with atorvastatin. The key outcomes include the apolipoprotein AI rate of catabolism and rate of production.
- Objective 2 is to test the hypothesis that the fibrate ABT335 and ER niacin progressively improve postprandial lipidemia by oral fat challenge when added sequentially to baseline therapy with atorvastatin. Key outcomes include the incremental area under the curve for triglycerides and high-density lipoprotein cholesterol.
- Objective 3 is to test the hypothesis that the fibrate ABT335 and ER niacin progressively improve markers of postabsorptive lipoproteins and metabolism when added sequentially to baseline therapy with atorvastatin. Key outcomes include a. fasting cholesterol efflux, b. HDL cholesterol, apolipoprotein A-I, and enzymes that remodel HDL, c. atherogenic lipoproteins, and d. markers of energy metabolism and e. markers of inflammation.
Additional Aims
- Objective 4 is to assess tolerability and adverse events when ABT335 and ER niacin are added sequentially to atorvastatin. Specifically, we will assess changes in hepatobiliary laboratory tests (including incidence of elevation), incidence of symptomatic myalgia, and incidence of flushing. On an exploratory basis, we will enhance the flushing evaluation with objective and subjective measurements of flushing during inpatient visits.
Study Design:
This is an open-label feasibility study of fixed-sequence addition of lipid-altering medications, in which comparisons are made to the baseline for each subject. Subjects begin a lead-in phase in which they start the study statin (atorvastatin) or switch from previous statin therapy to the study statin. Subjects will wash off other excluded lipid-altering drugs during the lead-in. Subjects return for the first inpatient visit, where they have baseline studies on statin monotherapy. At the end of this visit, subjects are started on fibrate therapy (ABT335). They repeat the studies on dual therapy with statin and fibrate, and then add niacin (ER niacin). To minimize flushing during chronic treatment, they start aspirin 325 mg daily, or titrate to 325 mg if they are taking a lower dose of aspirin (e.g. 81 mg). Finally, they repeat the studies on triple therapy with statin, fibrate, and niacin/aspirin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Active comparator | Drug: Atorvastatinatorvastatin 10 mg/day by mouth for a total duration of 4 weeks |
| ABT335 | Active comparator | Drug: Atorvastatin, Drug: ABT335ABT335 135 mg/day by mouth added to atorvastatin for a total duration of at least 8 |
| ER niacin | Active comparator | Drug: Atorvastatin, Drug: ABT335, Drug: ER NiacinER niacin titrated up to 2 g/day with aspirin 325 mg/day by mouth added to atorvastatin and ABT335 for 10 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men/women aged 18-80 years.
- Low HDL-C, adjusted for baseline statin use
- TG/HDL ratio >= 3.5
- Able to understand and agree to informed consent
- Women of child-bearing age must test negative on a urine pregnancy test and agree to use reliable birth control during the study and for 1 month after last dose of study drugs. Reliable methods include oral contraceptives, a barrier method, intrauterine device, partner with vasectomy, or abstinence.
Key exclusion criteria (38 listed)
- Subjects with following lipoprotein disorders:
- Use of non-statin lipid therapy prior to study initiation is exclusionary if (n.b. washout of non-statins is permitted):
- Intolerance to statin, fibrate, aspirin, deuterated leucine, or niacin
- Contraindications to medications, including chronic muscle disease, history of rhabdomyolysis, moderate-severe gout, severe peptic ulcer disease, bleeding disorders, and aspirin-sensitive asthma.
- Diabetics, or fasting glucose > 110 mg/dL on two different days during screening, or use of anti-diabetic medications within 6 weeks of screening visit
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 |
|---|---|---|
| AtorvastatinAlso: Lipitor10 mg QD for 4 weeks | Drug | ABT335, Atorvastatin, ER niacin |
| ABT335Also: Trilipex135 mg QD added to atorvastatin for 8 weeks | Drug | ABT335, ER niacin |
| ER NiacinAlso: Niaspan2000 mg QD added to atorvastatin and ABT335 for 10 weeks | Drug | ER niacin |
Primary outcome
The Apolipoprotein A-I Fractional Catabolic Rate (FCR)
Time frame: 4 weeks, 12 weeks and 22 weeks
After receiving total daily caloric intake over 20 hrs as 20 identical small meals, starting at 0600 hrs, subjects took study medications at 0800 hrs. Five hours after the first meal, i.v. 5,5,5-2H3-L-leucine was administered, followed by a primed-constant infusion at 10 mol/kg body weight per hr for 15 hrs during which 14 blood samples were collected. Isotopic enrichment of leucine in apoA1 band excised from polyacrylamide gel was calculated. Assuming steady state apo A-I metabolism, we used a compartment model to fit data, consisting a precursor compartment (Compartment 1), the plasma leucine pool, an intracellular compartment accounting for apoA1 synthesis and lipoprotein assembly (Compartment 2), and compartments to account for dispositional kinetics of the subfractions including a plasma pool compartment (Compartment 3). The apoA1 FCR corresponds to the rate of irreversible loss of leucine pools from Compartment 3.
Apo-A1 Production Rate
Time frame: 4 weeks, 12 weeks and 22 weeks
The apolipoprotein A-I production rate using (5,5,5-2H3-L-leucine) was measured following each of the three study periods i.e following 4 weeks of atorvastatin 10 mg/day, following 8 further weeks of ABT335 135 mg/day added to atorvastatin and following 10 further weeks of ER niacin 2000 mg/day and aspirin 325 mg/day added to atorvastatin+ABT335.
Post-prandial Triglyceride Incremental Area Under the Curve (iAUC)
Time frame: 4 weeks, 12 weeks, 22 weeks
Triglyceride iAUC was measured during an oral fat tolerance test administered after 4 weeks of atorvastatin 10 mg/day , a further 8 weeks of atorvastatin 10mg /day+ABT335 135mg/day and then after a further 10 weeks of atorvastatin 10 mg/day+ABT335 135 mg/day+Niaspan 2000 mg/day. The standardized oral fat load was administered one hour post medication dosing and blood was collected prior to drug dosing, prior to the oral fat load and hourly thereafter for 10 hours (0,1,2,3,4,5,6,7,8,9,10,12 hrs post drug dosing)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard L Dunbar, MD principal investigator
University of Pennsylvania
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 Atorvastatin, ABT335 and ER Niacin in people with Dyslipidemia, run by University of Pennsylvania at 1 site in United States.
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 8 inclusion and 38 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 29 Feb 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Apolipoprotein A-I Fractional Catabolic Rate (FCR) (time frame: 4 weeks, 12 weeks and 22 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 29 Feb 2016.