HypertensionPhase 3NCT00389519
A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents
A Phase 3 study testing ramipril in people with Hypertension, run by Pfizer at 100 sites in 9 countries.
Trial summary
The primary purpose of this study is to evaluate the blood pressure lowering effects of ramipril, an FDA-approved drug for the treatment of hypertension in adults, in children and adolescents aged 6 to 16 years with hypertension. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Hypertension
- What is being tested?
- ramipril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 422 participants
- Where
- 100 sitesin 9 countries
- Study dates
- Oct 2006to Nov 2007
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Previous, documented diagnosis of hypertension, or newly diagnosed hypertension according to the fourth report on the diagnosis, evaluation and treatment of high blood pressure in children and adolescents (United States). SiSBP greater than or equal to the 95th percentile for age, gender, and height.
- The subject can be safely withdrawn from antihypertensive medications during the screening period, and if given placebo during the treatment period in the judgment of the Investigator.
- The subject is male or female age 6 to 16 years (inclusive), and weighs greater than or equal to 20 kg.
- Female subjects greater than or equal to 12 years of age, or who have had greater than or equal to 1 menstruation must: (a) have a negative serum pregnancy test at screening (i.e., subject is not pregnant), (b) not be lactating, and (c) use an acceptable method of contraception.
- Parents/guardians are able to demonstrate their ability to (a) use a home blood pressure monitor supplied for the study to monitor their child's blood pressure, and (2) mix and administer a liquid dose of study drug if needed.
Who cannot join
- Bilateral renal artery stenosis.
- Uncorrected coarctation of the aorta or corrected coarctation with a right arm/right leg blood pressure gradient greater than 10 mmHg.
- Severe hypertension.
- Renal transplantation or other previous solid organ transplantation less than 6 months prior to entering the study.
- Subjects with nephrotic syndrome not on stable maintenance therapy of prednisone or cyclosporine.
- A history of cardiomyopathy, clinically significant structural heart disease, or atrioventricular conduction disturbance, sick sinus syndrome, atrial flutter, atrial fibrillation, clinically significant bradycardia or an accessory bypass tract, or clinical symptoms of congestive heart failure.
Show all 9Show fewer
- Clinically significant hematologic, hepatobiliary, or renal disease including a Schwartz formula GFR less than 40 mL/min/1.73 m2, and/or serum potassium (K+) greater than 5.5 mEq/L.
- History of pancreatitis (active or inactive).
- Known sensitivity to angiotensin converting enzyme inhibitors or a history of angioneurotic edema.
Trial locations and contacts
100 sites in 9 countries.
100 sites in 9 countries
United States39 sites
Emory University
Atlanta, Georgia, 30322
Medical College of Georgia
Augusta, Georgia, 30912
South East Texas Cardiology Associates
Beaumont, Texas, 77701
Impact Clinical Research
Beverly Hills, California, 90211
Craig Spiegel, MD
Bridgeton, Missouri, 63044
Western Wake Pediatrics
Cary, North Carolina, 27518
University of North Carolina
Chapel Hill, North Carolina, 27514
University of Virginia
Charlottesville, Virginia, 22908
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Pediatrics in Brevard
Cocoa Beach, Florida, 33155
Center for Clinical and Translational Research
Columbus, Ohio, 43205
Duke Pediatric Clinical Research Program
Durham, North Carolina, 27710
Hawaii Pacific Health
Honolulu, Hawaii, 96813
University of Texas Medical Center
Houston, Texas, 77030
Holston Medical Group
Kingsport, Tennessee, 37660
Watson Clinic Center for Research, Inc.
Lakeland, Florida, 33805
Impact Clinical Trials
Las Vegas, Nevada, 89106
Children's Heart Center
Las Vegas, Nevada, 89109
UAMS College of Medicine/ Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Woodland International Research Group, LLC
Little Rock, Arkansas, 72211
Neufeld Medical Group
Los Angeles, California, 90048
Kosair Children's Hospital
Louisville, Kentucky, 40202
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105
Huguenot Pediatrics
Midlothian, Virginia, 23113
Children's Specialty Group
Norfolk, Virginia, 23510
Central Sooner Research
Norman, Oklahoma, 73069
Almon Clinical Research, Inc.
Orange, California, 92868
Nephrology and Hypertension Consultants
Park Ridge, Illinois, 60068
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Oregon Health and Science University
Portland, Oregon, 97201
Northwest Pediatric Kidney Specialists, LLC
Portland, Oregon, 97227
University of Utah
Salt Lake City, Utah, 84108
Louisiana State University
Shreveport, Louisiana, 71103
North Carolina Children's and Adults Clinical Research Foundation
Sylva, North Carolina, 28779
SUNY Upstate Syracuse, Department of Pediatrics
Syracuse, New York, 13210
Tinley Park Pediatric Associates
Tinley Park, Illinois, 60477
Premier Clinical Research Group
Toms River, New Jersey, 08755
The University of Oklahoma
Tulsa, Oklahoma, 74135
Hartrich Aquino & Hrab, PC
Williamsville, New York, 14221
India13 sites
Gujarat Kidney Foundation, Jivraj Mehta Hospital
Ahmedabad
Heart Care Clinic
Ahmedabad
St. John's Hospital
Bangalore
Institute of Child Health & Hospital for Children
Chennai
AIl India Institute medical sciences
Delhi
Apollo Hospital
Delhi
Maulana Azad Medical College and Lok Nayak Hospital
Delhi
Apollo Hospital Hyderabad
Hyderabaad
Nizam's Institute of Medical Sciences
Hyderabaad
Christian Medical College and Hospital
Ludhiana
Jaslok Hospital and Research Centre
Mumbai
KEM Hospital Research Centre
Pune
Kerala Institute of Medical Science
Trivandrum
Poland10 sites
Klinika Nefrologii Dzieciecej SPSK nr 1 ACK AMG
Gdansk
Katedra i Klinika Kardiologii Dzieciecej SK nr 6, Gornoslaskie Centrum Zdrowia Dziecka i Matki, Slaska AM
Katowice
II Katedra Pediatrii, Klinika Kardiologii Dzieciecej UM w Lodzi
Lodz
Klinika Nefrologii i Dializoterapii, Instytut Centrum Zdrowia Matki Polki
Lodz
Klinika Kardiologii i Nefrologii Dzieciecej AM
Poznan
I Klinika Chorob Dzieci SPSK nr 1 PAM
Szczecin
Oddzial Nefrologi Dzieciecej ze Stacja Dializ SSP ZOZ nad Dziecklem i Mlodzieza
Szczecin
Oddzial Pediatrii i Nefrologii ze Stacja Dializ, Wojewodzki Szpital Dzieciecy
Torun
Klinika Nefrologii i Transplantacji Nerek, Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw
Klinika Nefrologii Pediatrycznej AM
Wroclaw
South Africa9 sites
Benmed Park Clinic
Benoni
Chris Hani Baragwanath
Johannesburg
Global Clinical Trial Centre
Port Elizabeth
Potchefstroom Medi-Clinic
Potchefstroom
Eastmed Medical centre
Pretoria
Jubilee CTC Jubilee Hospital
Pretoria
Pretoria Academic Hospital
Pretoria
Zuid Afrikaans Hospital
Pretoria
Sandton Clinical Research Centre
Sandton
Ukraine9 sites
Dnepropetrovsk Medical Academy, Department of Hospital Pediatrics on the bases of Regional Pediatric Hospital
Dnipro
Kharkov State University,Dept. of hospital pediatric on the bases of Regional Children's Hospital
Kharkiv
NMU n.b. Bogomolets, on b.o. Chil. Clin.Hosp.#2, Department of Pediatrics #2
Kiev
Institute of Pediatrics and Obstetrics AMS of Ukraine, Department of ecology related health problems
Kyiv
Danylo Halytskiy Lviv NationalMedical University, Department of Faculty
Lviv
Odessa State Medical University, Dept. of hospital pediatric and neonotology on the bases of Regional Children Hospital
Odesa
Crim.St. Med. Uni. On b.o. Rep. Child.Clin.Hosp. Chair of Pediat. W.c. of Physioth. Of the Postgr.dept
Simferopol
Uzhorod National University, Medical faculty, Department of Children's disease with course of Infection disease on the basis of City Children's Clinical Hospital.
Uzhhorod
Vinnitsa National Medical Academy, Department of Hospital Pediatrics on the bases of Regional Pediatric Hospital
Vinnitsa
Argentina6 sites
Hospital de Niños "Dr. Ricardo Gutiérrez"
Buenos Aires
Hospital General Interzonal "Dr. José Penna"
Buenos Aires
Hospital Interzonal Especializado Materno Infantil
Buenos Aires
Hospital Italiano de Buenos Aires
Buenos Aires
Hospital de Niños Juan Carlos Navarro
San Juan
Centro Infantil del Rínon
Tucomán
Colombia6 sites
Fundación Bios
Barranquilla
Fundación Cardio Infantil - Instituto de Cardiología
Bogotá
Hospital de San Jose
Bogotá
Instituto Nacional del Riñón
Bogotá
Hospital Pablo Tobon Uribe
Medellín
Hospital Universitario San Vicente de Paul
Medellín
Chile4 sites
Clínica Las Condes
Santiago
Hospital de Niños Roberto del Rio
Santiago
Hospital Luis Calvo Mackena
Santiago
Hospital Dr. Gustavo Fricke
Viña del Mar
Turkey (Türkiye)4 sites
Istanbul University Istanbul Medical Faculty Pediatric Nephrology
Istanbul
Marmara University Medical Faculty Pediatric Nephrology
Istanbul
Dokuzeylul University Medical Faculty Pediatric Nephrology
Izmir
Ondokummayis University Medical Faculty Pediatric Nephrology
Samsun
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Arm Study Assessing the Efficacy, Safety, and Dose-Response of Ramipril for the Treatment of Hypertension in Children and Adolescents
The primary purpose of this study is to evaluate the blood pressure lowering effects of ramipril, an FDA-approved drug for the treatment of hypertension in adults, in children and adolescents aged 6 to 16 years with hypertension.
Read the detailed description
Information is needed on the treatment of hypertension in children and adolescents with antihypertensive drugs like ramipril. The study will assess the safety and blood pressure effects of several doses of the antihypertensive drug ramipril in children and adolescents age 6-16 years. Approximately 450 children will be given placebo, or 1 of the 3 doses of ramipril. The treatment assigned will be done by chance, like flipping a coin. Approximately 120 study centers throughout the world will participate in the trial.
Each child will complete a 1- to 4-week Screening Period where they will stop taking their current blood pressure lowering drug(s), a 4-week Treatment Period where they will receive placebo or one of the ramipril doses, and a Follow-up visit 1 week after completion of the Treatment Period. Children diagnosed with hypertension according to the fourth report on the diagnosis, evaluation and treatment of high blood pressure in children and adolescents (U.S. report), will be included in the study if their blood pressure meets certain values.
Each child will complete a minimum of 6 and up to 9 clinic visits over the course of the study during which procedures and assessments of blood pressure and safety will be performed. In addition, a child's parents/guardians will be instructed to measure their child's blood pressure at home between clinic visits.
A planned interim analysis was performed after approximately 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis.
- Conditions
- Hypertension
- Being tested
- ramipril, placebo
- Keywords
- Hypertension/*etiology, Blood Pressure, Pediatric, Adolescent, Child
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ramiprilDrug
Also called Altace
once a day oral ramipril capsules given for 4 weeks
placeboDrug
once a day oral placebo capsule for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | once per day Receives: Drug: placebo |
| ramipril low dose | Experimental | 0.3125, 0.625, or 1.25 mg once a day, based on subject weight Receives: Drug: ramipril |
| ramipril mid dose | Experimental | 1.25, 2.5, or 5 mg once a day, based on subject weight Receives: Drug: ramipril |
| ramipril high dose | Experimental | 5, 10, or 20 mg once a day, based on subject weight Receives: Drug: ramipril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure
Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo
Measured: Baseline to 4 weeks
Secondary outcomes (4)
Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure
Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo
Measured: Baseline to 4 weeks
Change From Baseline to 4 Weeks in Serum Creatinine
Value at end of treatment (up to 4 weeks) minus value at baseline
Measured: Baseline up to 4 weeks
Change From Baseline to 4 Weeks in Serum Potassium
Value at end of treatment (up to 4 weeks) minus value at baseline
Measured: Baseline up to 4 weeks
Change From Baseline to 4 Weeks in Schwartz Formula Glomerular Filtration Rate (GFR)
Value at end of treatment (up to 4 weeks) minus value at baseline; GFR is a measure of kidney function.
Measured: Baseline up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionNov 2007
- Study completionNov 2007
Why it stopped: A planned interim analysis was performed after approx. 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis.
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.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389519
- Sponsor's protocol ID
- K726-06-4003
- Status last verified
- Jun 2012
- First submitted
- 17 Oct 2006
- Last updated
- 11 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Arm Study Assessing the Efficacy, Safety, and Dose-Response of Ramipril for the Treatment of Hypertension in Children and Adolescents
- ClinicalTrials.gov ID
- NCT00389519
- Acronym / sponsor ID
- K726-06-4003
- Conditions
- Hypertension
- Keywords
- Hypertension/*etiology, Blood Pressure, Pediatric, Adolescent, Child
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A planned interim analysis was performed after approx. 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis.
- Enrolment
- 422 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 19 Oct 2006 (estimated)
- Results
- Posted 19 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the blood pressure lowering effects of ramipril, an FDA-approved drug for the treatment of hypertension in adults, in children and adolescents aged 6 to 16 years with hypertension.
Detailed description
Information is needed on the treatment of hypertension in children and adolescents with antihypertensive drugs like ramipril. The study will assess the safety and blood pressure effects of several doses of the antihypertensive drug ramipril in children and adolescents age 6-16 years. Approximately 450 children will be given placebo, or 1 of the 3 doses of ramipril. The treatment assigned will be done by chance, like flipping a coin. Approximately 120 study centers throughout the world will participate in the trial.
Each child will complete a 1- to 4-week Screening Period where they will stop taking their current blood pressure lowering drug(s), a 4-week Treatment Period where they will receive placebo or one of the ramipril doses, and a Follow-up visit 1 week after completion of the Treatment Period. Children diagnosed with hypertension according to the fourth report on the diagnosis, evaluation and treatment of high blood pressure in children and adolescents (U.S. report), will be included in the study if their blood pressure meets certain values.
Each child will complete a minimum of 6 and up to 9 clinic visits over the course of the study during which procedures and assessments of blood pressure and safety will be performed. In addition, a child's parents/guardians will be instructed to measure their child's blood pressure at home between clinic visits.
A planned interim analysis was performed after approximately 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboonce per day |
| ramipril low dose | Experimental | Drug: ramipril0.3125, 0.625, or 1.25 mg once a day, based on subject weight |
| ramipril mid dose | Experimental | Drug: ramipril1.25, 2.5, or 5 mg once a day, based on subject weight |
| ramipril high dose | Experimental | Drug: ramipril5, 10, or 20 mg once a day, based on subject weight |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Previous, documented diagnosis of hypertension, or newly diagnosed hypertension according to the fourth report on the diagnosis, evaluation and treatment of high blood pressure in children and adolescents (United States). SiSBP greater than or equal to the 95th percentile for age, gender, and height.
- The subject can be safely withdrawn from antihypertensive medications during the screening period, and if given placebo during the treatment period in the judgment of the Investigator.
- The subject is male or female age 6 to 16 years (inclusive), and weighs greater than or equal to 20 kg.
- Female subjects greater than or equal to 12 years of age, or who have had greater than or equal to 1 menstruation must: (a) have a negative serum pregnancy test at screening (i.e., subject is not pregnant), (b) not be lactating, and (c) use an acceptable method of contraception.
- Parents/guardians are able to demonstrate their ability to (a) use a home blood pressure monitor supplied for the study to monitor their child's blood pressure, and (2) mix and administer a liquid dose of study drug if needed.
Key exclusion criteria (9 listed)
- Bilateral renal artery stenosis.
- Uncorrected coarctation of the aorta or corrected coarctation with a right arm/right leg blood pressure gradient greater than 10 mmHg.
- Severe hypertension.
- Renal transplantation or other previous solid organ transplantation less than 6 months prior to entering the study.
- Subjects with nephrotic syndrome not on stable maintenance therapy of prednisone or cyclosporine.
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 |
|---|---|---|
| ramiprilAlso: Altaceonce a day oral ramipril capsules given for 4 weeks | Drug | ramipril high dose, ramipril low dose, ramipril mid dose |
| placeboonce a day oral placebo capsule for 4 weeks | Drug | Placebo |
Primary outcome
Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure
Time frame: Baseline to 4 weeks
Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo
4 secondary outcomes
Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure
Time frame: Baseline to 4 weeks
Change From Baseline to 4 Weeks in Serum Creatinine
Time frame: Baseline up to 4 weeks
Change From Baseline to 4 Weeks in Serum Potassium
Time frame: Baseline up to 4 weeks
Change From Baseline to 4 Weeks in Schwartz Formula Glomerular Filtration Rate (GFR)
Time frame: Baseline up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
100 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ramipril in people with Hypertension, run by Pfizer at 100 sites in 9 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 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: stopped early, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 sites in United States, India, Poland, South Africa, Ukraine and 4 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 19 May 2010). 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 to 4 Weeks in Trough Sitting Systolic Blood Pressure (time frame: Baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2012.