HypertensionPhase 3NCT00935077
A Collaborative Model to Improve Blood Pressure (BP) Control and Minimize Racial Disparities
A Phase 3 study testing PPCM Asthma, 24 Month PPCM BP and 9 Month PPCM BP in people with Hypertension and Asthma, run by University of Iowa at 28 sites in United States.
Trial summary
The purpose of the study is to determine the degree to which pharmacist-physician collaborative management (PPCM) of hypertension can be adopted and implemented in clinics with geographic and racial diversity and whether patients in clinics which implement PPCM achieve greater blood pressure control than patients in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Asthma
- What is being tested?
- PPCM Asthma, 24 Month PPCM BP and 9 Month PPCM BP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,441 participants
- Where
- 28 sitesUnited States
- Study dates
- Jan 2010to Mar 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- English or Spanish speaking males or females, over 18 years of age with a diagnosis of hypertension,
- have uncontrolled BP defined as > 140 mm Hg SBP or > 90 mm Hg DBP for patients with uncomplicated hypertension; or > 130 mm Hg SBP or > 80 mm Hg DBP for patients with diabetes or chronic kidney disease, and
- receive care from one of the participating clinics.
Who cannot join
- current signs of hypertensive emergency (acute angina, stroke, or renal failure;
- severe HTN (systolic BP >200 or diastolic BP > 114 mm Hg);
- history of MI, stroke, or unstable angina in the prior 6 months;
- systolic dysfunction with a LV ejection fraction < 35% documented by echocardiography, nuclear medicine study, or ventriculography;
- renal insufficiency, defined by a glomerular filtration rate less than 20 ml/min or previously documented proteinuria > 1 gram per day;
- significant hepatic disease, including prior diagnoses of cirrhosis, Hepatitis B or C infection, or laboratory abnormalities (serum ALT or AST > 2 times control or total bilirubin > 1.5 mg/dl) in the prior 6 months;
Show all 11Show fewer
- pregnancy;
- diagnoses of pulmonary hypertension or sleep apnea (unless treated by continuous positive pressure ventilation);
- poor prognosis with a life expectancy estimated less than 2 years;
- residence in a nursing home or diagnosis of dementia; and
- inability to give informed consent or impaired cognitive function (defined as > 3 errors on the 10-item Pfeiffer Portable Mental Status Questionnaire, administered during study intake).
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Texas Tech University Health Science Center
Amarillo, Texas, 79106
Seton Healthcare
Austin, Texas, 78701
SUNY-University of Buffalo
Buffalo, New York, 14260
Cambridge Health Alliance
Cambridge, Massachusetts, 02139
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27559
Medical University of South Carolina
Charleston, South Carolina, 29425
Genesis Health System
Davenport, Iowa, 52803
Broadlawns Medical Center
Des Moines, Iowa, 50314
Midwestern University
Downers Grove, Illinois, 60515
Duke University
Durham, North Carolina, 27705
University of Texas at El Paso
El Paso, Texas, 79968
University of Florida
Gainesville, Florida, 32601
St. Francis Hospital Medical Center
Hartford, Connecticut, 06105
Memorial Hermann Hospital System
Houston, Texas, 77030
The University of Iowa
Iowa City, Iowa, 52242-1112
University of Wisconsin
Madison, Wisconsin, 53715
Wheaton Franciscan Medical Group
Milwaukee, Wisconsin, 53210
Temple University
Philadelphia, Pennsylvania, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Idaho State University
Pocatello, Idaho, 83209
University of Utah
Salt Lake City, Utah, 84112-5820
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
University of California San Diego
San Diego, California, 92093
Siouxland Medical Education Foundation
Sioux City, Iowa, 51104
Spartanburg Regional Health Service District
Spartanburg, South Carolina, 29303
University of South Florida
Tampa, Florida, 33612
Northeast Iowa Medical Education Foundation
Waterloo, Iowa, 50702
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Collaborative Model to Improve BP Control and Minimize Racial Disparities-CCC
The purpose of the study is to determine the degree to which pharmacist-physician collaborative management (PPCM) of hypertension can be adopted and implemented in clinics with geographic and racial diversity and whether patients in clinics which implement PPCM achieve greater blood pressure control than patients in clinics which do not implement PPCM.
Primary Hypothesis: BP control at 9 months will be significantly greater in patients from clinics randomized to the two PPCM BP intervention groups compared to the control group.
Read the detailed description
Blood pressure (BP) is controlled in only 34% of patients with high BP, leading to unnecessary strokes, myocardial infarctions and other cardiovascular events. BP control can be improved with physician/ pharmacist collaborative management (PPCM). Our long-range goal is to achieve excellent BP control rates using PPCM that can be implemented in private practices in diverse communities. The objective of this application is to conduct a large multi-center clinical trial in clinics with geographic, racial and ethnic diversity to determine the extent to which the model is implemented. This practice-based research network (PBRN) is unique with a large minority population and great diversity in operation and community size. This prospective, cluster-randomized trial uses 27 clinics, matched and randomized to the active intervention (2 groups) or a control group in 648 patients. Following 9 months of the intervention, one intervention group will continue the intervention following 9 months while the other will discontinue it. We will also randomize 18 patients per clinic into a passive observation group (n=486) to determine if PPCM is implemented more broadly in the clinic. Patients in all three groups will be followed for 24 months. We will accomplish our objectives and test our central hypothesis by pursing the following aims:
Aim 1: To determine if patients in clinics randomized to PPCM can achieve better BP control at 9 months compared to patients in clinics randomized to the control group.
Primary Hypothesis: BP control at 9 months will be significantly greater in patients from clinics randomized to the two PPCM BP intervention groups compared to the control group.
Aim 2: To determine if patients in clinics randomized to continuation of PPCM achieve better long-term BP control compared to patients in clinics randomized to discontinuation of PPCM after 9 months and to patients in control clinics.
Our innovative approach addresses critical organizational barriers and challenges existing approaches to achieving better BP control. This study is novel because it will: 1) be the largest study to test this model, 2) use a cluster randomized design to include many more clinics than previously used, 3) use a diverse group of clinics with broad geographic distribution, 4) include large numbers of patients from minority groups to assess potential health disparities, 5) evaluate whether the effect can be sustained long-term, 6) include standardized BP measurements rather than error-prone office BPs, 7) minimize selection bias, and 8) evaluate a "passive observation group" to evaluate dissemination of PPCM throughout the practice. We expect that our study will find a 6-8 mm Hg difference in systolic BP which would lead to 20-30% fewer coronary deaths and 25-40% fewer stroke deaths if applied across broadly across similar settings.
- Conditions
- Hypertension, Asthma
- Being tested
- PPCM Asthma, 24 Month PPCM BP, 9 Month PPCM BP
- Keywords
- Hypertension, Pharmacist Physician Collaborative Management of Hypertension
- Medical subject headings
- Hypertension, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPCM AsthmaOther
Pharmacists collaborate with physicians to manage asthma
24 Month PPCM BPOther
Pharmacists collaborate with physicians for 24 months to manage hypertension.
9 Month PPCM BPOther
Pharmacists collaborate with pharmacists for 9 months to manage hypertension
| Study group | Role | What they receive |
|---|---|---|
| 24 Month PPCM BP | Experimental | A 24 month long physician/pharmacist collaborative intervention is implemented to manage hypertension Receives: Other: 24 Month PPCM BP |
| 9 Month PPCM BP | Experimental | A 9 month long physician/pharmacist collaborative intervention is implemented to manage hypertension Receives: Other: 9 Month PPCM BP |
| PPCM Asthma | Sham comparator | A 9 month long physician/pharmacist collaborative intervention is implemented to manage asthma Receives: Other: PPCM Asthma |
| BP Control Arm | No intervention | No PPCM intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Control
Measured: 9 Months
Secondary outcomes (1)
Blood Pressure Control
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJan 2010
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,441 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barry L. Carter, PharmD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935077
- Sponsor's protocol ID
- 1R01HL091841
- Status last verified
- Jul 2014
- First submitted
- 6 Jul 2009
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anderegg MD, Gums TH, Uribe L, MacLaughlin EJ, Hoehns J, Bazaldua OV, Ives TJ, Hahn DL, Coffey CS, Carter BL. Pharmacist Intervention for Blood Pressure Control in Patients with Diabetes and/or Chronic Kidney Disease. Pharmacotherapy. 2018 Mar;38(3):309-318. doi: 10.1002/phar.2083. Epub 2018 Feb 23.
PubMed 29331037Anderegg MD, Gums TH, Uribe L, Coffey CS, James PA, Carter BL. Physician-Pharmacist Collaborative Management: Narrowing the Socioeconomic Blood Pressure Gap. Hypertension. 2016 Nov;68(5):1314-1320. doi: 10.1161/HYPERTENSIONAHA.116.08043. Epub 2016 Sep 6.
PubMed 27600181Carter BL. Primary Care Physician-Pharmacist Collaborative Care Model: Strategies for Implementation. Pharmacotherapy. 2016 Apr;36(4):363-73. doi: 10.1002/phar.1732. Epub 2016 Apr 6.
PubMed 26931738Isetts BJ, Buffington DE, Carter BL, Smith M, Polgreen LA, James PA. Evaluation of Pharmacists' Work in a Physician-Pharmacist Collaborative Model for the Management of Hypertension. Pharmacotherapy. 2016 Apr;36(4):374-84. doi: 10.1002/phar.1727. Epub 2016 Mar 18.
PubMed 26893135Carter BL, Coffey CS, Ardery G, Uribe L, Ecklund D, James P, Egan B, Vander Weg M, Chrischilles E, Vaughn T. Cluster-randomized trial of a physician/pharmacist collaborative model to improve blood pressure control. Circ Cardiovasc Qual Outcomes. 2015 May;8(3):235-43. doi: 10.1161/CIRCOUTCOMES.114.001283. Epub 2015 Mar 24.
PubMed 25805647Carter BL, Coffey CS, Uribe L, James PA, Egan BM, Ardery G, Chrischilles EA, Ecklund D, Vander Weg M, Vaughn T; Collaboration Among Pharmacists and Physicians to Improve Outcomes Now (CAPTION) trial investigators. Similar blood pressure values across racial and economic groups: baseline data from a group randomized clinical trial. J Clin Hypertens (Greenwich). 2013 Jun;15(6):404-12. doi: 10.1111/jch.12091. Epub 2013 Apr 1.
PubMed 23730989Demik DE, Vander Weg MW, Lundt ES, Coffey CS, Ardery G, Carter BL. Using theory to predict implementation of a physician-pharmacist collaborative intervention within a practice-based research network. Res Social Adm Pharm. 2013 Nov-Dec;9(6):719-30. doi: 10.1016/j.sapharm.2013.01.003. Epub 2013 Mar 16.
PubMed 23506651Carter BL, Clarke W, Ardery G, Weber CA, James PA, Vander Weg M, Chrischilles EA, Vaughn T, Egan BM; Collaboration Among Pharmacists Physicians To Improve Outcomes Now (CAPTION) Trial Investigators. A cluster-randomized effectiveness trial of a physician-pharmacist collaborative model to improve blood pressure control. Circ Cardiovasc Qual Outcomes. 2010 Jul;3(4):418-23. doi: 10.1161/CIRCOUTCOMES.109.908038.
PubMed 20647575
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Collaborative Model to Improve BP Control and Minimize Racial Disparities-CCC
- ClinicalTrials.gov ID
- NCT00935077
- Acronym / sponsor ID
- 1R01HL091841
- Conditions
- Hypertension, Asthma
- Keywords
- Hypertension, Pharmacist Physician Collaborative Management of Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,441 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the degree to which pharmacist-physician collaborative management (PPCM) of hypertension can be adopted and implemented in clinics with geographic and racial diversity and whether patients in clinics which implement PPCM achieve greater blood pressure control than patients in clinics which do not implement PPCM.
Primary Hypothesis: BP control at 9 months will be significantly greater in patients from clinics randomized to the two PPCM BP intervention groups compared to the control group.
Detailed description
Blood pressure (BP) is controlled in only 34% of patients with high BP, leading to unnecessary strokes, myocardial infarctions and other cardiovascular events. BP control can be improved with physician/ pharmacist collaborative management (PPCM). Our long-range goal is to achieve excellent BP control rates using PPCM that can be implemented in private practices in diverse communities. The objective of this application is to conduct a large multi-center clinical trial in clinics with geographic, racial and ethnic diversity to determine the extent to which the model is implemented. This practice-based research network (PBRN) is unique with a large minority population and great diversity in operation and community size. This prospective, cluster-randomized trial uses 27 clinics, matched and randomized to the active intervention (2 groups) or a control group in 648 patients. Following 9 months of the intervention, one intervention group will continue the intervention following 9 months while the other will discontinue it. We will also randomize 18 patients per clinic into a passive observation group (n=486) to determine if PPCM is implemented more broadly in the clinic. Patients in all three groups will be followed for 24 months. We will accomplish our objectives and test our central hypothesis by pursing the following aims:
Aim 1: To determine if patients in clinics randomized to PPCM can achieve better BP control at 9 months compared to patients in clinics randomized to the control group.
Primary Hypothesis: BP control at 9 months will be significantly greater in patients from clinics randomized to the two PPCM BP intervention groups compared to the control group.
Aim 2: To determine if patients in clinics randomized to continuation of PPCM achieve better long-term BP control compared to patients in clinics randomized to discontinuation of PPCM after 9 months and to patients in control clinics.
Our innovative approach addresses critical organizational barriers and challenges existing approaches to achieving better BP control. This study is novel because it will: 1) be the largest study to test this model, 2) use a cluster randomized design to include many more clinics than previously used, 3) use a diverse group of clinics with broad geographic distribution, 4) include large numbers of patients from minority groups to assess potential health disparities, 5) evaluate whether the effect can be sustained long-term, 6) include standardized BP measurements rather than error-prone office BPs, 7) minimize selection bias, and 8) evaluate a "passive observation group" to evaluate dissemination of PPCM throughout the practice. We expect that our study will find a 6-8 mm Hg difference in systolic BP which would lead to 20-30% fewer coronary deaths and 25-40% fewer stroke deaths if applied across broadly across similar settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 24 Month PPCM BP | Experimental | Other: 24 Month PPCM BPA 24 month long physician/pharmacist collaborative intervention is implemented to manage hypertension |
| 9 Month PPCM BP | Experimental | Other: 9 Month PPCM BPA 9 month long physician/pharmacist collaborative intervention is implemented to manage hypertension |
| PPCM Asthma | Sham comparator | Other: PPCM AsthmaA 9 month long physician/pharmacist collaborative intervention is implemented to manage asthma |
| BP Control Arm | No intervention | –No PPCM intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English or Spanish speaking males or females, over 18 years of age with a diagnosis of hypertension,
- have uncontrolled BP defined as > 140 mm Hg SBP or > 90 mm Hg DBP for patients with uncomplicated hypertension; or > 130 mm Hg SBP or > 80 mm Hg DBP for patients with diabetes or chronic kidney disease, and
- receive care from one of the participating clinics.
Key exclusion criteria (11 listed)
- current signs of hypertensive emergency (acute angina, stroke, or renal failure;
- severe HTN (systolic BP >200 or diastolic BP > 114 mm Hg);
- history of MI, stroke, or unstable angina in the prior 6 months;
- systolic dysfunction with a LV ejection fraction < 35% documented by echocardiography, nuclear medicine study, or ventriculography;
- renal insufficiency, defined by a glomerular filtration rate less than 20 ml/min or previously documented proteinuria > 1 gram per day;
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 |
|---|---|---|
| PPCM AsthmaPharmacists collaborate with physicians to manage asthma | Other | PPCM Asthma |
| 24 Month PPCM BPPharmacists collaborate with physicians for 24 months to manage hypertension. | Other | 24 Month PPCM BP |
| 9 Month PPCM BPPharmacists collaborate with pharmacists for 9 months to manage hypertension | Other | 9 Month PPCM BP |
Primary outcome
Blood Pressure Control
Time frame: 9 Months
1 secondary outcome
Blood Pressure Control
Time frame: 24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
- Derived from this study: PubMed 29331037Anderegg MD, Gums TH, Uribe L, MacLaughlin EJ, Hoehns J, Bazaldua OV, Ives TJ, Hahn DL, Coffey CS, Carter BL. Pharmacist Intervention for Blood Pressure Control in Patients with Diabetes and/or Chronic Kidney Disease. Pharmacotherapy. 2018 Mar;38(3):309-318. doi: 10.1002/phar.2083. Epub 2018 Feb 23.
- Derived from this study: PubMed 27600181Anderegg MD, Gums TH, Uribe L, Coffey CS, James PA, Carter BL. Physician-Pharmacist Collaborative Management: Narrowing the Socioeconomic Blood Pressure Gap. Hypertension. 2016 Nov;68(5):1314-1320. doi: 10.1161/HYPERTENSIONAHA.116.08043. Epub 2016 Sep 6.
- Derived from this study: PubMed 26931738Carter BL. Primary Care Physician-Pharmacist Collaborative Care Model: Strategies for Implementation. Pharmacotherapy. 2016 Apr;36(4):363-73. doi: 10.1002/phar.1732. Epub 2016 Apr 6.
- Derived from this study: PubMed 26893135Isetts BJ, Buffington DE, Carter BL, Smith M, Polgreen LA, James PA. Evaluation of Pharmacists' Work in a Physician-Pharmacist Collaborative Model for the Management of Hypertension. Pharmacotherapy. 2016 Apr;36(4):374-84. doi: 10.1002/phar.1727. Epub 2016 Mar 18.
- Derived from this study: PubMed 25805647Carter BL, Coffey CS, Ardery G, Uribe L, Ecklund D, James P, Egan B, Vander Weg M, Chrischilles E, Vaughn T. Cluster-randomized trial of a physician/pharmacist collaborative model to improve blood pressure control. Circ Cardiovasc Qual Outcomes. 2015 May;8(3):235-43. doi: 10.1161/CIRCOUTCOMES.114.001283. Epub 2015 Mar 24.
- Derived from this study: PubMed 23730989Carter BL, Coffey CS, Uribe L, James PA, Egan BM, Ardery G, Chrischilles EA, Ecklund D, Vander Weg M, Vaughn T; Collaboration Among Pharmacists and Physicians to Improve Outcomes Now (CAPTION) trial investigators. Similar blood pressure values across racial and economic groups: baseline data from a group randomized clinical trial. J Clin Hypertens (Greenwich). 2013 Jun;15(6):404-12. doi: 10.1111/jch.12091. Epub 2013 Apr 1.
- Derived from this study: PubMed 23506651Demik DE, Vander Weg MW, Lundt ES, Coffey CS, Ardery G, Carter BL. Using theory to predict implementation of a physician-pharmacist collaborative intervention within a practice-based research network. Res Social Adm Pharm. 2013 Nov-Dec;9(6):719-30. doi: 10.1016/j.sapharm.2013.01.003. Epub 2013 Mar 16.
- Derived from this study: PubMed 20647575Carter BL, Clarke W, Ardery G, Weber CA, James PA, Vander Weg M, Chrischilles EA, Vaughn T, Egan BM; Collaboration Among Pharmacists Physicians To Improve Outcomes Now (CAPTION) Trial Investigators. A cluster-randomized effectiveness trial of a physician-pharmacist collaborative model to improve blood pressure control. Circ Cardiovasc Qual Outcomes. 2010 Jul;3(4):418-23. doi: 10.1161/CIRCOUTCOMES.109.908038.
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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.
Barry L. Carter, PharmD principal investigator
University of Iowa
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PPCM Asthma, 24 Month PPCM BP and 9 Month PPCM BP in people with Hypertension and Asthma, run by University of Iowa at 28 sites 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 3 inclusion and 11 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 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood Pressure Control (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 NCT00935077, which also lists 8 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 10 Jul 2014.