Congestive Heart FailurePhase 1/2NCT01544998
Tadalafil and Nesiritide as Therapy in Pre-clinical Heart Failure
A Phase 1/2 study testing Nesiritide, Tadalafil and Saline load in people with Congestive Heart Failure, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to determine the effects of subcutaneous (under the skin) injection of human B-type natriuretic factor (BNP), Natrecor (nesiritide), a hormone produced by the heart, in combination with Tadalafil on: The pumping function of the heart Kidney function Hormonal function (levels of different… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Nesiritide, Tadalafil and Saline load
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Aug 2014
- Phase
- Phase 1/2
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group 1 (PSD)
- an ejection fraction of less than 45% with no clinical signs or symptoms of congestive heart failure;
- a minimal distance on 6-minute walk of >450 meters
- calculated creatinine clearance of equal or less than 90 ml/min and greater than 30 ml/min, using the Modification of Diet in Renal Disease (MDRD) formula assessed within the past 24 months. If the creatinine clearance is > 24 months a creatinine test can be drawn at screen/enrollment visit.
- A 6-minute walk distance of 450 meters
- Group 2 (PDD)
Show all 10Show fewer
- ejection fraction of greater than 50% with moderate or severe diastolic dysfunction as assessed by Doppler echocardiography,
- who do not have any signs or symptoms of congestive heart failure
- minimal distance on 6-minute walk of >450 meters
- calculated creatinine clearance of equal or less than 90 ml/min and greater than 30 ml/min
Who cannot join
- Current or anticipated future need for nitrate therapy
- Systolic blood pressure < 90 mmHg or > 180 mm Hg
- Diastolic blood pressure < 40 mmHg or > 100 mmHg
- Resting heart rate (HR) > 100 bpm
- Patients taking alpha antagonists or cytochrome P450 3A4 inhibitors (ketoconazole, itraconazole, erythromycin, saquinavir, cimetidine or serum protease inhibitors for HIV).
- Patients with retinitis pigmentosa, previous diagnosis of nonischemic optic neuropathy, untreated proliferative retinopathy or unexplained visual disturbance
Show all 26Show fewer
- Patients with sickle cell anemia, multiple myeloma, leukemia or penile deformities placing them at risk for priapism (angulation, cavernosal fibrosis or Peyronie's disease)
- Contraindication to nesiritide.
- Patients with an allergy to iodine.
- Valve disease (> moderate aortic or mitral stenosis; > moderate aortic or mitral regurgitation)
- Hypertrophic cardiomyopathy
- Infiltrative or inflammatory myocardial disease (amyloid, sarcoid)
- Pericardial disease
- Have experienced a myocardial infarction or unstable angina, or have undergone percutaneous transluminal coronary angiography (PTCA) or coronary artery bypass grafting (CABG) within 60 days prior to consent, or requires either PTCA or CABG at the time of consent
- Severe congenital heart diseases
- Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening
- Second or third degree heart block without a permanent cardiac pacemaker
- Stroke within 3 months of screening or other evidence of significantly compromised central nervous system (CNS) perfusion
- Patients with severe liver disease (AST > 3x normal, alkaline or bilirubin > 2x normal)
- Serum sodium of < 125 milliequivalents (mEq)/dL or > 150 mEq/dL
- Serum potassium of < 3.2 mEq/dL or > 5.7 mEq/dL
- Prior diagnosis of intrinsic renal diseases including renal artery stenosis of > 50%
- Peritoneal or hemodialysis within 90 days or anticipation that dialysis or ultrafiltration of any form will be required during the study period
- Less than 21 years of age
- Pregnant or nursing women.
- Women of child bearing potential who do not have a negative pregnancy test at study entry and who are not using effective contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Define the Role of PDEV in Mediating the Decreased GFR and Attenuated Renal Sodium and cGMP Excretory Response to Acute Saline Volume Expansion in PSD and PDD With Renal Dysfunction.
This study is being done to determine the effects of subcutaneous (under the skin) injection of human B-type natriuretic factor (BNP), Natrecor (nesiritide), a hormone produced by the heart, in combination with Tadalafil on:
- The pumping function of the heart
- Kidney function
- Hormonal function (levels of different hormones in your blood) in persons with lower pumping function of their heart.
Read the detailed description
In the American Heart Association/American College of Cardiology classification of heart failure (HF), stage B is defined as patients with abnormal heart structure/function (systolic or diastolic dysfunction) without symptoms. This concept of preclinical HF is based on the fact that abnormal heart structure/function can be detected by complementary methods before the development of symptoms. Patients with those abnormalities may progress to heart failure and are at increased risk of adverse cardiac events. Preclinical systolic dysfunction (PSD) is the initial compensated phase of left ventricular systolic dysfunction without symptoms of HF. We have established that diastolic dysfunction is common in the general population being present in approximately 25% of the population over age 45, the majority of whom are asymptomatic i.e., preclinical diastolic dysfunction (PDD). Cyclic guanosine monophosphate (cGMP) is the second messenger of the natriuretic peptide system (NPS) and the nitric oxide system (NO) and plays an important role in the preservation of myocardial, vascular, and renal function. Hence, disruption of this signal transduction process may contribute to the development of cardiorenal dysfunction. Type V phosphodiesterase (PDEV) metabolizes cGMP and is abundant in the kidney, vasculature, and has been recently reported in the heart. We and others have demonstrated that renal PDEV is up-regulated in experimental HF and may lead to the attenuation of renal cGMP generation in response to both endogenous and exogenous BNP, thus serving as a mechanism for renal resistance to BNP. Furthermore, in experimental overt HF, 10 days of PDEV inhibition treatment resulted in reduction of left ventricular (LV) mass, increased LV fractional shortening and cardiac output but did not improve renal function. However, chronic PDEV inhibition did enhance the renal actions of exogenous BNP, specifically improving glomerular filtration rate (GFR) and renal cGMP generation. PDEV inhibitors are FDA approved for erectile dysfunction and pulmonary hypertension.
- Conditions
- Congestive Heart Failure
- Being tested
- Nesiritide, Tadalafil, Placebo, Saline load
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NesiritideDrug
10 ug/kg
TadalafilDrug
Also called Cialis, Adcira
5 mg
PlaceboDrug
The pharmacy will create a placebo subcutaneous injection volume to match the volume of Nesiritide dose.
Saline loadDrug
Normal saline 0.9% 0.25 ml/kg/min for 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| Tadalafil plus Placebo, then Tadalafil plus Nesiritide | Experimental | First intervention period: oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. There was a one week washout period. Second intervention period: oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. Receives: Drug: Nesiritide; Drug: Tadalafil; Drug: Placebo; Drug: Saline load |
| Tadalafil plus Nesiritide, then Tadalafil plus Placebo | Experimental | First intervention period: oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. There was a one week washout period. Second intervention period: oral Tadalafil; after 1 hour, sc placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. Receives: Drug: Nesiritide; Drug: Tadalafil; Drug: Placebo; Drug: Saline load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group
Value at 60 minutes minus value at baseline.
Measured: Baseline, 60 minutes after saline load
Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group
Value at 60 minutes minus value at baseline.
Measured: Baseline, 60 minutes after saline load
Secondary outcomes (4)
Change in Glomerular Filtration Rate (GFR) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group
Value at 60 minutes minus value at baseline.
Measured: Baseline, 60 minutes after saline load
Change in Glomerular Filtration Rate (GFR) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group
Value at 60 minutes minus value at baseline.
Measured: Baseline, 60 minutes after saline load
Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group
Value at 60 minutes minus value at baseline.
Measured: Baseline, 60 minutes after saline load
Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group
Value at 60 minutes minus value at baseline.
Measured: Baseline, 60 minutes after saline load
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2013
- Study completionAug 2014
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Horng Chen, Mayo Clinic
- Investigators
- Horng H Chen, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544998
- Sponsor's protocol ID
- 11-004257
- Other IDs
- UL1RR024150, 5P01HL076611
- Status last verified
- Feb 2018
- First submitted
- 24 Jan 2012
- Last updated
- 22 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wan SH, McKie PM, Slusser JP, Burnett JC Jr, Hodge DO, Chen HH. Effects of phosphodiesterase V inhibition alone and in combination with BNP on cardiovascular and renal response to volume load in human preclinical diastolic dysfunction. Physiol Rep. 2021 Aug;9(16):e14974. doi: 10.14814/phy2.14974.
PubMed 34405565Wan SH, Torres-Courchoud I, McKie PM, Slusser JP, Redfield MM, Burnett JC Jr, Hodge DO, Chen HH. Cardiac Versus Renal Response to Volume Expansion in Preclinical Systolic Dysfunction With PDEV Inhibition and BNP. JACC Basic Transl Sci. 2019 Dec 23;4(8):962-972. doi: 10.1016/j.jacbts.2019.08.008. eCollection 2019 Dec.
PubMed 31909303
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Define the Role of PDEV in Mediating the Decreased GFR and Attenuated Renal Sodium and cGMP Excretory Response to Acute Saline Volume Expansion in PSD and PDD With Renal Dysfunction.
- ClinicalTrials.gov ID
- NCT01544998
- Acronym / sponsor ID
- 11-004257
- Conditions
- Congestive Heart Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2012 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 6 Mar 2012 (estimated)
- Results
- Posted 4 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to determine the effects of subcutaneous (under the skin) injection of human B-type natriuretic factor (BNP), Natrecor (nesiritide), a hormone produced by the heart, in combination with Tadalafil on:
- The pumping function of the heart
- Kidney function
- Hormonal function (levels of different hormones in your blood) in persons with lower pumping function of their heart.
Detailed description
In the American Heart Association/American College of Cardiology classification of heart failure (HF), stage B is defined as patients with abnormal heart structure/function (systolic or diastolic dysfunction) without symptoms. This concept of preclinical HF is based on the fact that abnormal heart structure/function can be detected by complementary methods before the development of symptoms. Patients with those abnormalities may progress to heart failure and are at increased risk of adverse cardiac events. Preclinical systolic dysfunction (PSD) is the initial compensated phase of left ventricular systolic dysfunction without symptoms of HF. We have established that diastolic dysfunction is common in the general population being present in approximately 25% of the population over age 45, the majority of whom are asymptomatic i.e., preclinical diastolic dysfunction (PDD). Cyclic guanosine monophosphate (cGMP) is the second messenger of the natriuretic peptide system (NPS) and the nitric oxide system (NO) and plays an important role in the preservation of myocardial, vascular, and renal function. Hence, disruption of this signal transduction process may contribute to the development of cardiorenal dysfunction. Type V phosphodiesterase (PDEV) metabolizes cGMP and is abundant in the kidney, vasculature, and has been recently reported in the heart. We and others have demonstrated that renal PDEV is up-regulated in experimental HF and may lead to the attenuation of renal cGMP generation in response to both endogenous and exogenous BNP, thus serving as a mechanism for renal resistance to BNP. Furthermore, in experimental overt HF, 10 days of PDEV inhibition treatment resulted in reduction of left ventricular (LV) mass, increased LV fractional shortening and cardiac output but did not improve renal function. However, chronic PDEV inhibition did enhance the renal actions of exogenous BNP, specifically improving glomerular filtration rate (GFR) and renal cGMP generation. PDEV inhibitors are FDA approved for erectile dysfunction and pulmonary hypertension.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tadalafil plus Placebo, then Tadalafil plus Nesiritide | Experimental | Drug: Nesiritide, Drug: Tadalafil, Drug: Placebo, Drug: Saline loadFirst intervention period: oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. There was a one week washout period. Second intervention period: oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. |
| Tadalafil plus Nesiritide, then Tadalafil plus Placebo | Experimental | Drug: Nesiritide, Drug: Tadalafil, Drug: Placebo, Drug: Saline loadFirst intervention period: oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. There was a one week washout period. Second intervention period: oral Tadalafil; after 1 hour, sc placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Group 1 (PSD)
- an ejection fraction of less than 45% with no clinical signs or symptoms of congestive heart failure;
- a minimal distance on 6-minute walk of >450 meters
- calculated creatinine clearance of equal or less than 90 ml/min and greater than 30 ml/min, using the Modification of Diet in Renal Disease (MDRD) formula assessed within the past 24 months. If the creatinine clearance is > 24 months a creatinine test can be drawn at screen/enrollment visit.
- A 6-minute walk distance of 450 meters
Key exclusion criteria (26 listed)
- Current or anticipated future need for nitrate therapy
- Systolic blood pressure < 90 mmHg or > 180 mm Hg
- Diastolic blood pressure < 40 mmHg or > 100 mmHg
- Resting heart rate (HR) > 100 bpm
- Patients taking alpha antagonists or cytochrome P450 3A4 inhibitors (ketoconazole, itraconazole, erythromycin, saquinavir, cimetidine or serum protease inhibitors for HIV).
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 |
|---|---|---|
| Nesiritide10 ug/kg | Drug | Tadalafil plus Nesiritide, then Tadalafil plus Placebo, Tadalafil plus Placebo, then Tadalafil plus Nesiritide |
| TadalafilAlso: Cialis, Adcira5 mg | Drug | Tadalafil plus Nesiritide, then Tadalafil plus Placebo, Tadalafil plus Placebo, then Tadalafil plus Nesiritide |
| PlaceboThe pharmacy will create a placebo subcutaneous injection volume to match the volume of Nesiritide dose. | Drug | Tadalafil plus Nesiritide, then Tadalafil plus Placebo, Tadalafil plus Placebo, then Tadalafil plus Nesiritide |
| Saline loadNormal saline 0.9% 0.25 ml/kg/min for 60 minutes | Drug | Tadalafil plus Nesiritide, then Tadalafil plus Placebo, Tadalafil plus Placebo, then Tadalafil plus Nesiritide |
Primary outcome
Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group
Time frame: Baseline, 60 minutes after saline load
Value at 60 minutes minus value at baseline.
Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group
Time frame: Baseline, 60 minutes after saline load
Value at 60 minutes minus value at baseline.
4 secondary outcomes
Change in Glomerular Filtration Rate (GFR) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group
Time frame: Baseline, 60 minutes after saline load
Change in Glomerular Filtration Rate (GFR) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group
Time frame: Baseline, 60 minutes after saline load
Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group
Time frame: Baseline, 60 minutes after saline load
Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group
Time frame: Baseline, 60 minutes after saline load
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34405565Wan SH, McKie PM, Slusser JP, Burnett JC Jr, Hodge DO, Chen HH. Effects of phosphodiesterase V inhibition alone and in combination with BNP on cardiovascular and renal response to volume load in human preclinical diastolic dysfunction. Physiol Rep. 2021 Aug;9(16):e14974. doi: 10.14814/phy2.14974.
- Derived from this study: PubMed 31909303Wan SH, Torres-Courchoud I, McKie PM, Slusser JP, Redfield MM, Burnett JC Jr, Hodge DO, Chen HH. Cardiac Versus Renal Response to Volume Expansion in Preclinical Systolic Dysfunction With PDEV Inhibition and BNP. JACC Basic Transl Sci. 2019 Dec 23;4(8):962-972. doi: 10.1016/j.jacbts.2019.08.008. eCollection 2019 Dec.
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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.
Horng H Chen, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nesiritide, Tadalafil and Saline load in people with Congestive Heart Failure, run by Mayo Clinic 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 10 inclusion and 26 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 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 4 Mar 2015). 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?
Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group (time frame: Baseline, 60 minutes after saline load). The study lists 2 primary outcomes in all. 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 NCT01544998, which also lists 2 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 22 Mar 2018.