Coronary Artery Disease (CAD)Phase 3AQUARIUSNCT00853827

Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients

A Phase 3 study testing Aliskiren in people with Coronary Artery Disease (CAD) and Coronary Atherosclerosis, run by Novartis Pharmaceuticals at 129 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range. Read more about this study

Who is it for?: Ages 35 years and older
Conditions the study is for: Coronary Artery Disease (CAD), Coronary Atherosclerosis
What is being tested?: Aliskiren
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 613 participants
Where: 129 sitesin 11 countries
Study dates: Mar 2009to Jan 2013
Phase: Phase 3
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 35 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with CAD who have blood pressure in the pre-hypertensive range defined as a msSBP ≥ 125 and ≤ 139mmHg and a msDBP < 90mmHg.
Patients with or without current treatment for hypertension
Angiographic evidence of coronary artery disease
At least 2 qualifying Cardiovascular risk factors at Visit 1

Who cannot join

Baseline IVUS determined unacceptable
Patients requiring treatment with disallowed study medications
Patients with clinically significant heart disease
Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left ventricular ejection fraction of < 25%
Patients requiring treatment with any 2 of the following classes of medication at Visit 1 or Visit 2:
Angiotensin converting enzyme inhibitors

Show all 9Show fewer

Angiotensin receptor blockers
aldosterone receptor blockers or a direct renin inhibitor.
Other conditions may apply

Trial locations and contacts

129 sites in 11 countries.

Country

City, postcode or hospital

129 sites in 11 countries

United States54 sites

Novartis Investigative Site
Albuquerque, New Mexico, 87131-5271
Novartis Investigative Site
Bend, Oregon, 97701
Novartis Investigative Site
Boston, Massachusetts
Novartis Investigative Site
Boulder, Colorado, 80304
Novartis Investigative Site
Buffalo, New York, 14215
Novartis Investigative Site
Cleveland, Ohio, 44109-1998
Novartis Investigative Site
Columbia, Maryland, 21044
Novartis Investigative Site
Columbia, Missouri, 65212
Novartis Investigative Site
Covington, Louisiana, 70433
Novartis Investigative Site
Dallas, Texas, 75226
Novartis Investigative Site
Danville, Pennsylvania, 17822-2001
Novartis Investigative Site
Decatur, Georgia, 30033
Novartis Investigative Site
Elkhart, Indiana, 46514
Novartis Investigative Site
Fargo, North Dakota, 58122
Novartis Investigative Site
Farmington, Connecticut, 06030-3100
Novartis Investigative Site
Flint, Michigan, 48532
Novartis Investigative Site
Gainesville, Florida, 32610
Novartis Investigative Site
Hillsboro, Oregon, 97123
Novartis Investigative Site
Hudson, Florida, 34667
Novartis Investigative Site
Johnson City, Tennessee, 37604
Novartis Investigative Site
Kalamazoo, Michigan, 49048
Novartis Investigative Site
Katy, Texas, 77493
Novartis Investigative Site
Lexington, Kentucky, 40536
Novartis Investigative Site
Los Angeles, California, 90033
Novartis Investigative Site
Los Angeles, California, 90095
Novartis Investigative Site
Louisville, Kentucky, 40202
Novartis Investigative Site
Memphis, Tennessee, 38104
Novartis Investigative Site
Miami, Florida, 33137-3732
Novartis Investigative Site
Midland, Michigan, 48640
Novartis Investigative Site
Mobile, Alabama, 36693
Novartis Investigative Site
New York, New York, 10011
Novartis Investigative Site
Oak Ridge, Tennessee, 37830
Novartis Investigative Site
Oklahoma City, Oklahoma, 73109
Novartis Investigative Site
Petoskey, Michigan, 49770
Novartis Investigative Site
Phoenix, Arizona, 85054
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15213
Novartis Investigative Site
Port Charlotte, Florida, 33952
Novartis Investigative Site
Raleigh, North Carolina, 27610
Novartis Investigative Site
Ridgewood, New Jersey, 07450
Novartis Investigative Site
Rochester, Minnesota, 55905-0001
Novartis Investigative Site
Safety Harbor, Florida, 34695
Novartis Investigative Site
Saginaw, Michigan, 48601
Novartis Investigative Site
Saint Paul, Minnesota, 55102
Novartis Investigative Site
San Antonio, Texas, 78229-3900
Novartis Investigative Site
San Diego, California, 92161
Novartis Investigative Site
Stockton, California, 95204
Novartis Investigative Site
Syracuse, New York, 13210-1640
Novartis Investigative Site
Torrance, California, 90502
Novartis Investigative Site
Tucson, Arizona, 85723-0001
Novartis Investigative Site
Tucson, Arizona, 85745
Novartis Investigative Site
Tulsa, Oklahoma, 74104-4243
Novartis Investigative Site
Washington D.C., District of Columbia, 20010
Novartis Investigative Site
Washington D.C., District of Columbia, 20037
Novartis Investigative Site
Williamsville, New York, 14221

Other trials in United States

Spain13 sites

Novartis Investigative Site
Barcelona, Barcelona, 08025
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Galdakano, Basque Country, 48960
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907
Novartis Investigative Site
Madrid, Madrid, 28040
Novartis Investigative Site
Madrid, Madrid, 28046
Novartis Investigative Site
Majadanonda, Madrid, 28220
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Oviedo, Principality of Asturias, 33006
Novartis Investigative Site
Santander, Cantabria, 39008
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
Novartis Investigative Site
Vigo, Galicia, 36200

Other trials in Spain

Italy10 sites

Novartis Investigative Site
Arezzo, AR, 52100
Novartis Investigative Site
Bergamo, BG, 24128
Novartis Investigative Site
Massa, MS, 54100
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Novara, 28100
Novartis Investigative Site
Parma, PR, 43100
Novartis Investigative Site
Roma, RM, 00185
Novartis Investigative Site
Rozzano, MI, 20089
Novartis Investigative Site
Sesto San Giovanni, MI, 20099
Novartis Investigative Site
Siena, SI, 53100

Other trials in Italy

Canada9 sites

Novartis Investigative Site
Chicoutimi, Quebec, G7H 5H6
Novartis Investigative Site
Edmonton, Alberta, T5H 3V9
Novartis Investigative Site
Edmonton, Alberta, T6G 2B7
Novartis Investigative Site
London, Ontario, N6A 5A5
Novartis Investigative Site
Montreal, Quebec, H1T 1C8
Novartis Investigative Site
Montreal, Quebec, H1T 2M4
Novartis Investigative Site
Québec, Quebec, G1V 4G5
Novartis Investigative Site
Toronto, Ontario, M4N 3M5
Novartis Investigative Site
Winnipeg, Manitoba, R2H 3C3

Other trials in Canada

Germany9 sites

Novartis Investigative Site
Coburg, 96450
Novartis Investigative Site
Essen, 45122
Novartis Investigative Site
Frankfurt, 60316
Novartis Investigative Site
Hamburg, 20099
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Leipzig, 04289
Novartis Investigative Site
Ludwigshafen, 67063
Novartis Investigative Site
München, 81737
Novartis Investigative Site
Neuss, 41464

Other trials in Germany

Argentina8 sites

Novartis Investigative Site
Buenos Aires, Buenos Aires, C1039AAP
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1210AAP
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1280AEB
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1426ANZ
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1428DCO
Novartis Investigative Site
Buenos Aires, Buenos Aires F.D., C1180AAX
Novartis Investigative Site
Corrientes, Corrientes Province, 3400
Novartis Investigative Site
Rosario, Santa Fe Province, C2000DSR

Other trials in Argentina

Belgium8 sites

Novartis Investigative Site
Aalst, Belgium, 9300
Novartis Investigative Site
Aalst, 9300
Novartis Investigative Site
Anderlecht, 1070
Novartis Investigative Site
Brussels, 1000
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Charleroi, 6000
Novartis Investigative Site
Genk, 3600
Novartis Investigative Site
Ottignies, 1340

Other trials in Belgium

Australia5 sites

Novartis Investigative Site
Adelaide, South Australia, 5000
Novartis Investigative Site
Camperdown, New South Wales, 2050
Novartis Investigative Site
Clayton, Victoria, 3168
Novartis Investigative Site
Liverpool, New South Wales, 2170
Novartis Investigative Site
New Lambton Heights, New South Wales, 2305

Other trials in Australia

Hungary5 sites

Novartis Investigative Site
Budapest, Hungary, 1122
Novartis Investigative Site
Budapest, 1134
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Pécs, Baranya, 7621
Novartis Investigative Site
Szeged, 6720

Other trials in Hungary

France4 sites

Novartis Investigative Site
Créteil, 94010
Novartis Investigative Site
Le Plessis-Robinson, 92350
Novartis Investigative Site
Pessac, 33604
Novartis Investigative Site
Toulouse, 31059

Other trials in France

Poland4 sites

Novartis Investigative Site
Bialystok, 15-276
Novartis Investigative Site
Krakow, Poland, 31-531
Novartis Investigative Site
Lódz, 90-549
Novartis Investigative Site
Warsaw, 04-628

Other trials in Poland

About this study

Official title: A 104 Week, Randomized, Double Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy of Aliskiren on the Progression of Atherosclerosis in Patients With Coronary Artery Disease When Added to Optimal Background Therapy

Conditions: Coronary Artery Disease (CAD), Coronary Atherosclerosis
Being tested: Placebo, Aliskiren
Keywords: CAD, coronary artery disease, coronary atherosclerosis, coronary angiography, IVUS, intravascular ultrasound, plasma renin activity, renin angiotensin aldosterone system,, direct renin inhibitors, coronary atheroma
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Placebo
AliskirenDrug
300 mg

Study groups in NCT00853827
Study group	Role	What they receive
1	Placebo comparator	Not described Receives: Drug: Placebo
2	Experimental	Aliskiren 300 mg Receives: Drug: Aliskiren

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment
Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases
Measured: Baseline, 104 weeks

Secondary outcomes (3)

Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS
Change from baseline in normalized total atheroma volume (TAV) (mm^3) for all matched slices of anatomically comparable segments of the target coronary artery were assess by IVUS after 104 weeks of treatment. calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases
Measured: Baseline, 104 weeks
Patients That Demonstrated Evidence of Atheroma Regression
Atheroma regression is defined as change from baseline to endpoint in PAV <0 .
Measured: Baseline to endpoint (104 weeks)
Number of Patients With Adverse Events, Serious Adverse Events, and Death
overall safety and tolerability of aliskiren 300 mg compared to placebo in patients with CAD and BP in the pre-hypertensive (high normal) range with or without treatment for hypertension following 104 weeks of treatment. Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity.
Measured: 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Jan 2013

First posted2 Mar 2009 (estimated)
Study startMar 2009
Primary completionJan 2013
Study completionJan 2013

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 Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 613 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00853827
Sponsor's protocol ID: CSPP100A2366
Other IDs: 2008-006447-40, 2008
Acronym: AQUARIUS
Status last verified: May 2014
First submitted: 26 Feb 2009
Last updated: 3 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Puri R, Nissen SE, Menon V, Shao M, Hsu A, Bakris GL, Kastelein JJ, Williams B, Armbrecht J, Brunel P, Kataoka Y, Nicholls SJ. Effects of aliskiren in diabetic and non-diabetic patients with coronary artery disease: Insights from AQUARIUS. Atherosclerosis. 2015 Dec;243(2):553-9. doi: 10.1016/j.atherosclerosis.2015.10.019. Epub 2015 Oct 20.
PubMed 26523993
Nicholls SJ, Bakris GL, Kastelein JJ, Menon V, Williams B, Armbrecht J, Brunel P, Nicolaides M, Hsu A, Hu B, Fang H, Puri R, Uno K, Kataoka Y, Bash D, Nissen SE. Effect of aliskiren on progression of coronary disease in patients with prehypertension: the AQUARIUS randomized clinical trial. JAMA. 2013 Sep 18;310(11):1135-44. doi: 10.1001/jama.2013.277169.
PubMed 23999933

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease (CAD) trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 104 Week, Randomized, Double Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy of Aliskiren on the Progression of Atherosclerosis in Patients With Coronary Artery Disease When Added to Optimal Background Therapy
ClinicalTrials.gov ID: NCT00853827
Acronym / sponsor ID: AQUARIUS / CSPP100A2366
Conditions: Coronary Artery Disease (CAD), Coronary Atherosclerosis
Keywords: CAD, coronary artery disease, coronary atherosclerosis, coronary angiography, IVUS, intravascular ultrasound, plasma renin activity, renin angiotensin aldosterone system,
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 613 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: The Cleveland Clinic
Study start: Mar 2009
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 2 Mar 2009 (estimated)
Results: Posted 7 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Placebo comparator	Drug: Placebo
2	Experimental	Drug: AliskirenAliskiren 300 mg

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients with CAD who have blood pressure in the pre-hypertensive range defined as a msSBP ≥ 125 and ≤ 139mmHg and a msDBP < 90mmHg.
Patients with or without current treatment for hypertension
Angiographic evidence of coronary artery disease
At least 2 qualifying Cardiovascular risk factors at Visit 1

Key exclusion criteria (9 listed)

Baseline IVUS determined unacceptable
Patients requiring treatment with disallowed study medications
Patients with clinically significant heart disease
Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left ventricular ejection fraction of < 25%
Patients requiring treatment with any 2 of the following classes of medication at Visit 1 or Visit 2:

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
PlaceboPlacebo	Drug	1
Aliskiren300 mg	Drug	2

Primary outcome

Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment
Time frame: Baseline, 104 weeks
Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases

3 secondary outcomes

Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS
Time frame: Baseline, 104 weeks
Patients That Demonstrated Evidence of Atheroma Regression
Time frame: Baseline to endpoint (104 weeks)
Number of Patients With Adverse Events, Serious Adverse Events, and Death
Time frame: 104 weeks

Results and safety

Results posted to the registry on 7 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aliskiren	652	613
Placebo	0	0

Primary outcome: Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment

Time frame: Baseline, 104 weeks. Least squares mean (Standard Error). Unit: percentage of baseline

Measure	Aliskiren n = 225	Placebo n = 233
Value	-0.33 (0.18)	0.11 (0.18)

Population analysed: Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization. All patients who had a valid baseline and post baseline IVUS measurement and post-baseline IVUS measurement and at least ≥72 weeks of treatment were included in this analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aliskiren 300 mg	76 of 305 (24.9%)	186 of 305 (61%)	Not reported
Placebo	97 of 308 (31.5%)	175 of 308 (56.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26523993Puri R, Nissen SE, Menon V, Shao M, Hsu A, Bakris GL, Kastelein JJ, Williams B, Armbrecht J, Brunel P, Kataoka Y, Nicholls SJ. Effects of aliskiren in diabetic and non-diabetic patients with coronary artery disease: Insights from AQUARIUS. Atherosclerosis. 2015 Dec;243(2):553-9. doi: 10.1016/j.atherosclerosis.2015.10.019. Epub 2015 Oct 20.
Derived from this study: PubMed 23999933Nicholls SJ, Bakris GL, Kastelein JJ, Menon V, Williams B, Armbrecht J, Brunel P, Nicolaides M, Hsu A, Hu B, Fang H, Puri R, Uno K, Kataoka Y, Bash D, Nissen SE. Effect of aliskiren on progression of coronary disease in patients with prehypertension: the AQUARIUS randomized clinical trial. JAMA. 2013 Sep 18;310(11):1135-44. doi: 10.1001/jama.2013.277169.

Related trials for Coronary Artery Disease (CAD)

Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
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Not yet recruitingObservational study
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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.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

Novartis study director

Novartis

129 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aliskiren in people with Coronary Artery Disease (CAD) and Coronary Atherosclerosis, run by Novartis Pharmaceuticals at 129 sites in 11 countries.

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 4 inclusion and 9 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 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Spain, Italy, Canada, Germany and 6 more countries. 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?

Yes. Results are posted in the registry (first posted 7 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?

Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment (time frame: Baseline, 104 weeks). 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 NCT00853827, 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 3 Jun 2014.