HypertensionPhase 3ACCELERATENCT00797862
Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension
A Phase 3 study testing Amlodipine, hydrochlorothiazide and Aliskiren in people with Hypertension, run by Novartis at 10 sites in 10 countries.
Trial summary
This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Amlodipine, hydrochlorothiazide and Aliskiren
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,254 participants
- Where
- 10 sitesin 10 countries
- Study dates
- Nov 2008to Nov 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients ≥ 18 years of age
- Participants with essential hypertension:
- Naive participants must have a mean sitting Systolic Blood Pressure (msSBP) ≥ 150 mmHg and < 180 mmHg at Visit 1 and Visit 2. (Participants are considered 'naïve' if they have never been treated with any antihypertensive medication.)
- All participants must have a msSBP ≥ 150 mmHg and < 180 mmHg at Visit 2
- Written informed consent to participate in this study prior to any study procedures
Who cannot join
- Severe hypertension
- Pregnant or nursing (lactating) women
- Pre-menopausal women not taking accepted form of birth control
- Serum potassium ≥ 5.5 mEq/L (mmol/L) at Visit 1
- History of cardiovascular conditions
- Uncontrolled Type 1 or Type 2 diabetes mellitus
- Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
10 sites in 10 countries.
10 sites in 10 countries
About this study
Official title: A Randomized, 32 Week Double-blind, Parallel-group, Multicenter Study to Compare the Efficacy and Safety of Initiating Treatment With Combination (Aliskiren/Amlodipine) Therapy in Comparison With the Sequential add-on Treatment Strategies in Patients With Essential Hypertension
This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension.
Read the detailed description
This study was designed to evaluate if patients with hypertension treated early with a combination therapy would achieve better blood pressure (BP) control, than patients being treated with a classical sequential add-on therapy.
The study compared the effects of the two treatment strategies: Treatment initiation on a single compound, either with aliskiren or amlodipine, and then continuation with the combination of both versus treatment initiation with the combination of aliskiren/amlodipine and then continuation with the combination. The study also evaluated if the overall mean sitting systolic blood pressure (msSBP)-lowering effect during the study, as well as the change from baseline to study end in msSBP, are superior in the group having received combination therapy from the beginning.
The study further evaluated the BP-lowering efficacy and tolerability of both treatment strategies.
- Conditions
- Hypertension
- Being tested
- Amlodipine, hydrochlorothiazide, Aliskiren
- Keywords
- Aliskiren, Amlodipine, Hypertension, SPA1000, Norvasc
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
Also called Norvasc
Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily.
hydrochlorothiazideDrug
Also called Esidrix, HydroDIURIL, Oretic, Ezide
Hydrochlorothiazide 12.5 mg capsules were taken orally once daily
AliskirenDrug
Also called SPA 100
Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren + Amlodipine | Experimental | Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks. Receives: Drug: Amlodipine; Drug: hydrochlorothiazide; Drug: Aliskiren |
| Aliskiren Start - Amlodipine Add-On | Experimental | Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks. Receives: Drug: Amlodipine; Drug: hydrochlorothiazide; Drug: Aliskiren |
| Amlodipine Start- Aliskiren Add-On | Experimental | Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks. Receives: Drug: Amlodipine; Drug: hydrochlorothiazide; Drug: Aliskiren |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks
Systolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msSBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures Analysis of Covariance (ANCOVA) model with treatment, visit, and region as factors, treatment by visit interaction and baseline msSBP as a covariate.
Measured: Baseline, 8 weeks, 16 weeks, and 24 weeks
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24
Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region as factors, treatment by visit interaction and baseline msSBP as a covariate.
Measured: Baseline to 24 weeks
Secondary outcomes (4)
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32
Diastolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at Week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 and 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msDBP a covariate.
Measured: Baseline to 32 weeks
Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks
Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msDBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures ANCOVA model with treatment, visit and regions as factors, treatment by visit interaction and baseline msDBP as a covariate.
Measured: Baseline, 8 weeks, 16 weeks and 24 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24
Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region, as factors, treatment by visit interaction and baseline msDBP as a covariate.
Measured: Baseline to 24 weeks
Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints
Systolic \& Diastolic Blood Pressure were measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and after 8, 16 , 24 and 32 weeks. Outcome is reported as percentage of participants achieving overall blood pressure control (msSBP <140 mmHg and msDBP <90 mmHg) at weeks 8, 16, 24 \& 32 endpoints.
Measured: Baseline to week 8, 16, 24 and 32 endpoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2010
- Study completionNov 2010
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 HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797862
- Sponsor's protocol ID
- CSPA100A2307
- Acronym
- ACCELERATE
- Status last verified
- Jun 2011
- First submitted
- 24 Nov 2008
- Last updated
- 17 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Brown MJ, Williams B, Morant SV, Webb DJ, Caulfield MJ, Cruickshank JK, Ford I, McInnes G, Sever P, Salsbury J, Mackenzie IS, Padmanabhan S, MacDonald TM; British Hypertension Society's Prevention and Treatment of Hypertension with Algorithm-based Therapy (PATHWAY) Studies Group. Effect of amiloride, or amiloride plus hydrochlorothiazide, versus hydrochlorothiazide on glucose tolerance and blood pressure (PATHWAY-3): a parallel-group, double-blind randomised phase 4 trial. Lancet Diabetes Endocrinol. 2016 Feb;4(2):136-47. doi: 10.1016/S2213-8587(15)00377-0. Epub 2015 Oct 18.
PubMed 26489809Brown MJ, McInnes GT, Papst CC, Zhang J, MacDonald TM. Aliskiren and the calcium channel blocker amlodipine combination as an initial treatment strategy for hypertension control (ACCELERATE): a randomised, parallel-group trial. Lancet. 2011 Jan 22;377(9762):312-20. doi: 10.1016/S0140-6736(10)62003-X. Epub 2011 Jan 12.
PubMed 21236483
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 32 Week Double-blind, Parallel-group, Multicenter Study to Compare the Efficacy and Safety of Initiating Treatment With Combination (Aliskiren/Amlodipine) Therapy in Comparison With the Sequential add-on Treatment Strategies in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT00797862
- Acronym / sponsor ID
- ACCELERATE / CSPA100A2307
- Conditions
- Hypertension
- Keywords
- Aliskiren, Amlodipine, Hypertension, SPA1000, Norvasc
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,254 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 25 Nov 2008 (estimated)
- Results
- Posted 17 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension.
Detailed description
This study was designed to evaluate if patients with hypertension treated early with a combination therapy would achieve better blood pressure (BP) control, than patients being treated with a classical sequential add-on therapy.
The study compared the effects of the two treatment strategies: Treatment initiation on a single compound, either with aliskiren or amlodipine, and then continuation with the combination of both versus treatment initiation with the combination of aliskiren/amlodipine and then continuation with the combination. The study also evaluated if the overall mean sitting systolic blood pressure (msSBP)-lowering effect during the study, as well as the change from baseline to study end in msSBP, are superior in the group having received combination therapy from the beginning.
The study further evaluated the BP-lowering efficacy and tolerability of both treatment strategies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aliskiren + Amlodipine | Experimental | Drug: Amlodipine, Drug: hydrochlorothiazide, Drug: AliskirenEligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks. |
| Aliskiren Start - Amlodipine Add-On | Experimental | Drug: Amlodipine, Drug: hydrochlorothiazide, Drug: AliskirenEligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks. |
| Amlodipine Start- Aliskiren Add-On | Experimental | Drug: Amlodipine, Drug: hydrochlorothiazide, Drug: AliskirenEligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female outpatients ≥ 18 years of age
- Participants with essential hypertension:
- Written informed consent to participate in this study prior to any study procedures
Key exclusion criteria (8 listed)
- Severe hypertension
- Pregnant or nursing (lactating) women
- Pre-menopausal women not taking accepted form of birth control
- Serum potassium ≥ 5.5 mEq/L (mmol/L) at Visit 1
- History of cardiovascular conditions
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 |
|---|---|---|
| AmlodipineAlso: NorvascAmlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily. | Drug | Aliskiren + Amlodipine, Aliskiren Start - Amlodipine Add-On, Amlodipine Start- Aliskiren Add-On |
| hydrochlorothiazideAlso: Esidrix, HydroDIURIL, Oretic, EzideHydrochlorothiazide 12.5 mg capsules were taken orally once daily | Drug | Aliskiren + Amlodipine, Aliskiren Start - Amlodipine Add-On, Amlodipine Start- Aliskiren Add-On |
| AliskirenAlso: SPA 100Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily. | Drug | Aliskiren + Amlodipine, Aliskiren Start - Amlodipine Add-On, Amlodipine Start- Aliskiren Add-On |
Primary outcome
Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks
Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks
Systolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msSBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures Analysis of Covariance (ANCOVA) model with treatment, visit, and region as factors, treatment by visit interaction and baseline msSBP as a covariate.
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24
Time frame: Baseline to 24 weeks
Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region as factors, treatment by visit interaction and baseline msSBP as a covariate.
4 secondary outcomes
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32
Time frame: Baseline to 32 weeks
Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks
Time frame: Baseline, 8 weeks, 16 weeks and 24 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24
Time frame: Baseline to 24 weeks
Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints
Time frame: Baseline to week 8, 16, 24 and 32 endpoints
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26489809Brown MJ, Williams B, Morant SV, Webb DJ, Caulfield MJ, Cruickshank JK, Ford I, McInnes G, Sever P, Salsbury J, Mackenzie IS, Padmanabhan S, MacDonald TM; British Hypertension Society's Prevention and Treatment of Hypertension with Algorithm-based Therapy (PATHWAY) Studies Group. Effect of amiloride, or amiloride plus hydrochlorothiazide, versus hydrochlorothiazide on glucose tolerance and blood pressure (PATHWAY-3): a parallel-group, double-blind randomised phase 4 trial. Lancet Diabetes Endocrinol. 2016 Feb;4(2):136-47. doi: 10.1016/S2213-8587(15)00377-0. Epub 2015 Oct 18.
- Derived from this study: PubMed 21236483Brown MJ, McInnes GT, Papst CC, Zhang J, MacDonald TM. Aliskiren and the calcium channel blocker amlodipine combination as an initial treatment strategy for hypertension control (ACCELERATE): a randomised, parallel-group trial. Lancet. 2011 Jan 22;377(9762):312-20. doi: 10.1016/S0140-6736(10)62003-X. Epub 2011 Jan 12.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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 study chair
Novartis
10 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amlodipine, hydrochlorothiazide and Aliskiren in people with Hypertension, run by Novartis at 10 sites in 10 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 5 inclusion and 8 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 17 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada, Costa Rica, France, Germany, Greece and 5 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. 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 17 May 2011). 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?
Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks (time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks). 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 NCT00797862, 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 17 Oct 2011.