Proteinuric Kidney DiseasePhase 4NCT01129557
Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease
A Phase 4 study testing Aliskiren and Valsartan in people with Proteinuric Kidney Disease and Diabetic Nephropathy, run by Columbia University at 1 site in United States.
Trial summary
Primary Hypothesis: Aldosterone breakthrough will occur at a far lower frequency during renin inhibition (0-10% over 9 months), alone or in combination with an ARB, compared to conventional ARB therapy (35-45% over 9 months). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proteinuric Kidney Disease, Diabetic Nephropathy, Hypertensive Nephrosclerosis
- What is being tested?
- Aliskiren and Valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proteinuria > 300 mg/day
- Normal to mildly reduced kidney function (eGFR > 45 ml/min/1.73m2)
- Systolic blood pressure >130 mm Hg
- Diastolic blood pressure >70 mm Hg
- Diagnoses of diabetic nephropathy, hypertensive nephrosclerosis, IgA nephropathy, focal segmental glomerulosclerosis, membranoproliferative glomerulonephritis, membranous nephropathy, fibrillary glomerulonephritis, or obesity-associated glomerulopathy
Who cannot join
- Concomitant use of cyclosporine (which can interact with aliskiren)
- Inability to undergo 6 week washout period if already on RAAS-blocking drug(s) (includes renin inhibitor, ACE-inhibitor, ARB, and mineralocorticoid receptor blocker)
- eGFR < 45 ml/min/1.73m2
- Urine protein excretion < 300 mg/day
- Serum K > 5.0 mEq/l
- Systolic blood pressure > 170 mm Hg or < 130 mm Hg after washout period
Show all 17Show fewer
- Diastolic blood pressure > 110 mm Hg or < 70 mm Hg after washout period
- Congestive heart failure NYHA class III and IV
- History of any cardiovascular events (stroke, TIA, MI, unstable angina, CABG, PCI, CHF hospitalization) in 3 months prior to study visit 1
- 2nd or 3rd degree heart block without a pacemaker or other uncontrolled arrhythmia
- Clinically significant valvular disease
- Known renal artery stenosis
- Any surgical or medical condition that might significantly alter the pharmacokinetics of the study drugs (n.b. bariatric surgery > 6 months prior to visit 1 is not an exclusion)
- History or evidence of drug or alcohol abuse within the last 12 months
- Any concurrent life threatening condition with a life expectancy less than 2 years
- Pregnant or nursing (lactating) women
- Women of child-bearing potential unless postmenopausal for at least 1 year, surgically sterile, or using effective methods of contraception as defined by local health authorities
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Aldosterone Breakthrough During Diovan (Valsartan), Tekturna (Aliskiren), and Combination (Valsartan+Aliskiren) Anti-hypertensive Therapy in Patients With Proteinuric Kidney Disease
Primary Hypothesis: Aldosterone breakthrough will occur at a far lower frequency during renin inhibition (0-10% over 9 months), alone or in combination with an ARB, compared to conventional ARB therapy (35-45% over 9 months). The investigators hypothesize that aldosterone breakthrough occurs due to accumulation of active precursor substances, most notably angiotensin II, produced in response to conventional RAAS blockade with ACEinhibitors and ARBs. The investigators believe that direct renin inhibition (DRI) should minimize this accumulation and therefore significantly lower or possibly eliminate the breakthrough effect.
Interruption of the renin-angiotensin-aldosterone system (RAAS) with angiotensin-converting enzyme inhibitors (ACE-Is) and angiotensin receptor blockers (ARBs), alone and in combination, has become a leading therapy to slow the progression of chronic heart and kidney disease. Both types of drugs inhibit the formation of aldosterone, a hormone, which has been shown to have harmful effects on patients with chronic heart and kidney disorders. This treatment is effective but not perfect since, even after an initial improvement, many patients become worse over the long term. This may be due to an unexpected increase in aldosterone, a phenomenon called "aldosterone breakthrough."
The purpose of this study is to find out whether the use of a direct renin inhibitor (DRI) alone, or in combination with an angiotensin receptor blocker (ARB), will lessen the occurrence of aldosterone breakthrough since direct renin inhibitors inhibit the formation of aldosterone at a very early step. This study will compare the effectiveness of adding Diovan (valsartan) or Tekturna (aliskiren) or a combination of Diovan and Tekturna to the usual antihypertensive treatment. The investigators will follow blood pressure, aldosterone levels, and urinary protein levels over 9 months to evaluate which of these therapies is most effective for treating hypertension in patients with proteinuric kidney disease.
Read the detailed description
This is a randomized, open-label, three-arm study comparing Diovan (valsartan, an ARB), Tekturna (aliskiren, a DRI), and the combination of valsartan + aliskiren (i.e. ARB + DRI). One hundred twenty subjects (40 per arm) will be treated with Tekturna, Diovan, or a combination of both drugs for 9 months on top of their usual antihypertensive treatment. Changes in urinary aldosterone excretion will be monitored during therapy to measure the incidence of aldosterone breakthrough, defined as any sustained positive change from baseline urinary aldosterone excretion by the completion of the 9-month study period. This frequency measure will be compared during ARB, DRI, and ARB + DRI therapy. Changes in urinary protein excretion will also be monitored alongside the urinary aldosterone levels to determine whether aldosterone breakthrough is associated with refractory proteinuria. This is an innovative study that will be the first to (1) examine aldosterone breakthrough during DRI therapy, and (2) explore whether addition of a DRI to an ARB protects against aldosterone breakthrough. In addition, this will be the first study to examine whether DRI therapy (alone or in combination with ARB) is effective therapy for hypertension in patients with non-diabetic proteinuric kidney disease.
- Conditions
- Proteinuric Kidney Disease, Diabetic Nephropathy, Hypertensive Nephrosclerosis, IgA Nephropathy, Focal Segmental Glomerulosclerosis, Glomerulopathy (Obesity-associated)
- Being tested
- Aliskiren, Valsartan
- Medical subject headings
- Diabetic Nephropathies, Glomerulonephritis, IGA, Glomerulosclerosis, Focal Segmental, Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
Also called Tekturna
ValsartanDrug
Also called Diovan
| Study group | Role | What they receive |
|---|---|---|
| Tekturna | Active comparator | Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months Receives: Drug: Aliskiren |
| Diovan | Active comparator | Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months Receives: Drug: Valsartan |
| Tekturna & Diovan | Active comparator | Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily \& Diovan (Valsartan), an angiotensin receptor (ARB) 160 mg by mouth once daily for 9 months Receives: Drug: Aliskiren; Drug: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of Aldosterone Breakthrough in Subjects Who Completed the 9-month Study Protocol.
The primary outcome of this study is the 9-month cumulative incidence of aldosterone breakthrough, defined as a sustained increase in 24-hour urine aldosterone above baseline, in each treatment arm.
Measured: 9 months
Secondary outcomes (11)
Serum Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.
Mean serum aldosterone at baseline, 3-, 6-, and 9-months.
Measured: Baseline, 3-, 6-, and 9-months
Urine Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.
Mean urine aldosterone at baseline, 3-, 6-, and 9-months.
Measured: Baseline, 3-, 6-, and 9-months
Serum Potassium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.
Mean serum potassium at baseline, 3-, 6-, and 9-months. (given as reference to interpret contemporaneous plasma \& urine aldosterone measurements.)
Measured: Baseline, 3-, 6-, and 9-months
Mean 24-hour Urine Sodium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.
Mean 24-hour urine sodium (mmol/day) at baseline, 3-, 6-, and 9-months. (given as reference to interpret contemporaneous plasma \& urine aldosterone measurements.)
Measured: Baseline, 3-, 6-, and 9-months
Pre- and Post-treatment Blood Pressure in Subjects With and Without Aldosterone Breakthrough.
Compares baseline and final (9 month) blood pressure for subjects with and without aldosterone breakthrough
Measured: Baseline and Final (9 month)
Pre- and Post-treatment Serum Creatinine in Subjects With and Without Aldosterone Breakthrough.
Compares baseline and final (9 month) serum creatinine for subjects with and without aldosterone breakthrough
Measured: Baseline and Final (9 month)
Pre- and Post-treatment Serum Potassium in Subjects With and Without Aldosterone Breakthrough.
Compares baseline and final (9 month) serum potassium for subjects with and without aldosterone breakthrough
Measured: Baseline and Final (9 month)
Pre- and Post-treatment 24-hour Urine Protein in Subjects With and Without Aldosterone Breakthrough.
Compares baseline and final (9 month) 24-hour urine protein for subjects with and without aldosterone breakthrough
Measured: Baseline and Final (9 month)
Pre- and Post-treatment 24-hour Urine Sodium in Subjects With and Without Aldosterone Breakthrough.
Compares baseline and final (9 month) 24-hour urine sodium for subjects with and without aldosterone breakthrough
Measured: Baseline and Final (9 month)
Pre- and Post-treatment 24-urine Aldosterone in Subjects With and Without Aldosterone Breakthrough.
Compares baseline and final (9 month) 24-hour urine aldosterone for subjects with and without aldosterone breakthrough
Measured: Baseline and Final (9 month)
Pre- and Post-treatment Serum Aldosterone in Subjects With and Without Aldosterone Breakthrough.
Compares baseline and final (9 month) serum aldosterone for subjects with and without aldosterone breakthrough
Measured: Baseline and Final (9 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startSep 2009
- Primary completionJan 2012
- Study completionDec 2012
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 (1)Papers the sponsor has linked to this study.
- Other trials for Proteinuric Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Pietro Canetta, MD, Columbia University
- Investigators
- Pietro Canetta, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129557
- Sponsor's protocol ID
- AAAE0863
- Other IDs
- #IIRP-906
- Status last verified
- Apr 2014
- First submitted
- 21 May 2010
- Last updated
- 15 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bomback AS, Rekhtman Y, Klemmer PJ, Canetta PA, Radhakrishnan J, Appel GB. Aldosterone breakthrough during aliskiren, valsartan, and combination (aliskiren + valsartan) therapy. J Am Soc Hypertens. 2012 Sep-Oct;6(5):338-45. doi: 10.1016/j.jash.2012.07.003.
PubMed 22995802
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aldosterone Breakthrough During Diovan (Valsartan), Tekturna (Aliskiren), and Combination (Valsartan+Aliskiren) Anti-hypertensive Therapy in Patients With Proteinuric Kidney Disease
- ClinicalTrials.gov ID
- NCT01129557
- Acronym / sponsor ID
- AAAE0863
- Conditions
- Proteinuric Kidney Disease, Diabetic Nephropathy, Hypertensive Nephrosclerosis, IgA Nephropathy, Focal Segmental Glomerulosclerosis, Glomerulopathy (Obesity-associated)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Sep 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Posted 15 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Hypothesis: Aldosterone breakthrough will occur at a far lower frequency during renin inhibition (0-10% over 9 months), alone or in combination with an ARB, compared to conventional ARB therapy (35-45% over 9 months). The investigators hypothesize that aldosterone breakthrough occurs due to accumulation of active precursor substances, most notably angiotensin II, produced in response to conventional RAAS blockade with ACEinhibitors and ARBs. The investigators believe that direct renin inhibition (DRI) should minimize this accumulation and therefore significantly lower or possibly eliminate the breakthrough effect.
Interruption of the renin-angiotensin-aldosterone system (RAAS) with angiotensin-converting enzyme inhibitors (ACE-Is) and angiotensin receptor blockers (ARBs), alone and in combination, has become a leading therapy to slow the progression of chronic heart and kidney disease. Both types of drugs inhibit the formation of aldosterone, a hormone, which has been shown to have harmful effects on patients with chronic heart and kidney disorders. This treatment is effective but not perfect since, even after an initial improvement, many patients become worse over the long term. This may be due to an unexpected increase in aldosterone, a phenomenon called "aldosterone breakthrough."
The purpose of this study is to find out whether the use of a direct renin inhibitor (DRI) alone, or in combination with an angiotensin receptor blocker (ARB), will lessen the occurrence of aldosterone breakthrough since direct renin inhibitors inhibit the formation of aldosterone at a very early step. This study will compare the effectiveness of adding Diovan (valsartan) or Tekturna (aliskiren) or a combination of Diovan and Tekturna to the usual antihypertensive treatment. The investigators will follow blood pressure, aldosterone levels, and urinary protein levels over 9 months to evaluate which of these therapies is most effective for treating hypertension in patients with proteinuric kidney disease.
Detailed description
This is a randomized, open-label, three-arm study comparing Diovan (valsartan, an ARB), Tekturna (aliskiren, a DRI), and the combination of valsartan + aliskiren (i.e. ARB + DRI). One hundred twenty subjects (40 per arm) will be treated with Tekturna, Diovan, or a combination of both drugs for 9 months on top of their usual antihypertensive treatment. Changes in urinary aldosterone excretion will be monitored during therapy to measure the incidence of aldosterone breakthrough, defined as any sustained positive change from baseline urinary aldosterone excretion by the completion of the 9-month study period. This frequency measure will be compared during ARB, DRI, and ARB + DRI therapy. Changes in urinary protein excretion will also be monitored alongside the urinary aldosterone levels to determine whether aldosterone breakthrough is associated with refractory proteinuria. This is an innovative study that will be the first to (1) examine aldosterone breakthrough during DRI therapy, and (2) explore whether addition of a DRI to an ARB protects against aldosterone breakthrough. In addition, this will be the first study to examine whether DRI therapy (alone or in combination with ARB) is effective therapy for hypertension in patients with non-diabetic proteinuric kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tekturna | Active comparator | Drug: AliskirenTekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months |
| Diovan | Active comparator | Drug: ValsartanDiovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months |
| Tekturna & Diovan | Active comparator | Drug: Aliskiren, Drug: ValsartanTekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily \& Diovan (Valsartan), an angiotensin receptor (ARB) 160 mg by mouth once daily for 9 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Proteinuria > 300 mg/day
- Normal to mildly reduced kidney function (eGFR > 45 ml/min/1.73m2)
- Systolic blood pressure >130 mm Hg
- Diastolic blood pressure >70 mm Hg
- Diagnoses of diabetic nephropathy, hypertensive nephrosclerosis, IgA nephropathy, focal segmental glomerulosclerosis, membranoproliferative glomerulonephritis, membranous nephropathy, fibrillary glomerulonephritis, or obesity-associated glomerulopathy
Key exclusion criteria (17 listed)
- Concomitant use of cyclosporine (which can interact with aliskiren)
- Inability to undergo 6 week washout period if already on RAAS-blocking drug(s) (includes renin inhibitor, ACE-inhibitor, ARB, and mineralocorticoid receptor blocker)
- eGFR < 45 ml/min/1.73m2
- Urine protein excretion < 300 mg/day
- Serum K > 5.0 mEq/l
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AliskirenAlso: Tekturna | Drug | Tekturna, Tekturna & Diovan |
| ValsartanAlso: Diovan | Drug | Diovan, Tekturna & Diovan |
Primary outcome
Cumulative Incidence of Aldosterone Breakthrough in Subjects Who Completed the 9-month Study Protocol.
Time frame: 9 months
The primary outcome of this study is the 9-month cumulative incidence of aldosterone breakthrough, defined as a sustained increase in 24-hour urine aldosterone above baseline, in each treatment arm.
11 secondary outcomes
Serum Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.
Time frame: Baseline, 3-, 6-, and 9-months
Urine Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.
Time frame: Baseline, 3-, 6-, and 9-months
Serum Potassium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.
Time frame: Baseline, 3-, 6-, and 9-months
Mean 24-hour Urine Sodium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.
Time frame: Baseline, 3-, 6-, and 9-months
Pre- and Post-treatment Blood Pressure in Subjects With and Without Aldosterone Breakthrough.
Time frame: Baseline and Final (9 month)
Pre- and Post-treatment Serum Creatinine in Subjects With and Without Aldosterone Breakthrough.
Time frame: Baseline and Final (9 month)
Pre- and Post-treatment Serum Potassium in Subjects With and Without Aldosterone Breakthrough.
Time frame: Baseline and Final (9 month)
Pre- and Post-treatment 24-hour Urine Protein in Subjects With and Without Aldosterone Breakthrough.
Time frame: Baseline and Final (9 month)
Pre- and Post-treatment 24-hour Urine Sodium in Subjects With and Without Aldosterone Breakthrough.
Time frame: Baseline and Final (9 month)
Pre- and Post-treatment 24-urine Aldosterone in Subjects With and Without Aldosterone Breakthrough.
Time frame: Baseline and Final (9 month)
Pre- and Post-treatment Serum Aldosterone in Subjects With and Without Aldosterone Breakthrough.
Time frame: Baseline and Final (9 month)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22995802Bomback AS, Rekhtman Y, Klemmer PJ, Canetta PA, Radhakrishnan J, Appel GB. Aldosterone breakthrough during aliskiren, valsartan, and combination (aliskiren + valsartan) therapy. J Am Soc Hypertens. 2012 Sep-Oct;6(5):338-45. doi: 10.1016/j.jash.2012.07.003.
Related trials for Proteinuric Kidney Disease
RecruitingPhase 2
PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease
Proteinuric Kidney Diseases
Active, not recruitingPhase 2/3
Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1-Mediated Proteinuric Kidney Disease
Proteinuric Kidney Disease
RecruitingPhase 2
Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases
Minimal Change Disease (MCD), IgA Nephropathy (IgAN)
RecruitingPhase 1
Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria
Proteinuric Renal Disease, Proteinuric Kidney Disease
RecruitingPhase 2
A Phase 2 Study of MZE829 in Adults With APOL1 Kidney Disease
Proteinuric Kidney Disease
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.
Pietro Canetta, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aliskiren and Valsartan in people with Proteinuric Kidney Disease and Diabetic Nephropathy, run by Columbia University 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 5 inclusion and 17 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: stopped early, as of the sponsor's last update on 15 May 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2014). 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?
Cumulative Incidence of Aldosterone Breakthrough in Subjects Who Completed the 9-month Study Protocol. (time frame: 9 months). 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 NCT01129557, which also lists 1 linked publication.
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 15 May 2014.