Uncontrolled HypertensionNCT01418261
SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension
A study testing Renal denervation (Symplicity Catheter System) and Renal angiogram in people with Uncontrolled Hypertension, run by Medtronic Vascular at 79 sites in United States.
Trial summary
The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- Renal denervation (Symplicity Catheter System) and Renal angiogram
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 535 participants
- Where
- 79 sitesUnited States
- Study dates
- Sep 2011to 17 Feb 2017
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individual is ≥ 18 and ≤ 80 years old at time of randomization.
- Individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 2 weeks prior to screening) that is expected to be maintained without changes for at least 6 months.
- Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit
Who cannot join
- Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
- Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP < 135 mmHg
- Individual has type 1 diabetes mellitus
- Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
- Individual has primary pulmonary hypertension.
- Individual is pregnant, nursing or planning to be pregnant.
Trial locations and contacts
79 sites in 1 country.
79 sites in 1 country
United States79 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Piedmont Heart Institute
Atlanta, Georgia, 30309
University of Colorado Hospital
Aurora, Colorado, 80045
Austin Heart PLLC / Heart Hospital of Austin
Austin, Texas, 78756
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Cardiology, PC
Birmingham, Alabama, 35211
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
VA Boston Healthcare System
Boston, Massachusetts, 02132
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Deborah Heart & Lung Center
Browns Mills, New Jersey, 08015
Lahey Clinic
Burlington, Massachusetts, 01805
Fletcher Allen Health Care
Burlington, Vermont, 05401
University of North Carolina Heart and Vascular
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
Carolinas Healthcare (SHVI)-Clinical Research
Charlotte, North Carolina, 28203
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
The Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, 45219
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
The MetroHealth System
Cleveland, Ohio, 44109
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210
OhioHealth Research Institute
Columbus, Ohio, 43214-3907
VA North Texas Health Care System
Dallas, Texas, 75216
Soltero Cardiovascular Research Center - Baylor Jack and Jane Hamilton Heart & Vascular Hospital
Dallas, Texas, 75226
Geisinger Medical Center
Danville, Pennsylvania, 17822
Iowa Heart Center Research
Des Moines, Iowa, 50266
Harper University Hospital - Detroit Medical Center
Detroit, Michigan, 48201
Duke University Health System
Durham, North Carolina, 27710
Shands / University of Florida
Gainesville, Florida, 32610
Hattiesburg Clinic, P.A
Hattiesburg, Mississippi, 39401
The Methodist Hospital
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
Saint Luke's Hospital of Kansas City/Mid America Heart Institute
Kansas City, Missouri, 64111
Scripps Clinic/Scripps Green Hospital
La Jolla, California, 92037
Lancaster General Hospital
Lancaster, Pennsylvania, 17604
University of Kentucky
Lexington, Kentucky, 40536
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California, 90027
Cedars Sinai Medical Center
Los Angeles, California, 90048
Stern Cardiovascular Foundation, Inc.
Memphis, Tennessee, 38138
University Of Miami
Miami, Florida, 33136
Baptist Cardiac &Vascular Institute, Baptist Health Systems
Miami, Florida, 33176
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Abbott Northwestern/Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Morristown Medical Center
Morristown, New Jersey, 07962
Vanderbilt Medical Center
Nashville, Tennessee, 37232-7235
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Ochsner Medical Center
New Orleans, Louisiana, 70121
New York University Medical Center
New York, New York, 10015
Weill Cornell Medical College
New York, New York, 10021
Mount Sinai Medical Center-Manhattan
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Midwest Heart Foundation
Oakbrook Terrace, Illinois, 60181
St. Joseph Hospital
Orange, California, 92868
Thomas Jefferson University Hospitals, Inc
Philadelphia, Pennsylvania, 19107
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19130
UPMC
Pittsburgh, Pennsylvania, 15213
The Heart Hospital Baylor Plano
Plano, Texas, 75093
St Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Vascular Disease Research Center at Rhode Island Hospital
Providence, Rhode Island, 02903
Virginia Commonwealth University
Richmond, Virginia, 23298
Saint Mary's Mayo Clinic
Rochester, Minnesota, 55905
St. Francis Hospital
Roslyn, New York, 11576
San Diego Cardiac Center
San Diego, California, 92123
Providence Hospital
Southfield, Michigan, 48075
Prairie Heart Institute
Springfield, Illinois, 62701
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305
Stony Brook University Hospital and Medical Center
Stony Brook, New York, 11794
Tampa General Hospital
Tampa, Florida, 33606
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Howard University Hospital
Washington D.C., District of Columbia, 20060
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Michigan Heart, St. Joseph Mercy Health System
Ypsilanti, Michigan, 48197
About this study
Official title: Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)
The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.
Read the detailed description
The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.
- Conditions
- Uncontrolled Hypertension
- Being tested
- Renal denervation (Symplicity Catheter System), Renal angiogram
- Keywords
- uncontrolled hypertension, renal denervation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervation (Symplicity Catheter System)Device
Renal angiogramDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Experimental | Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications Receives: Device: Renal denervation (Symplicity Catheter System); Diagnostic Test: Renal angiogram |
| Control group | Sham comparator | Subjects go through renal angiogram and Subjects maintained baseline anti-hypertensive medications Receives: Diagnostic Test: Renal angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Office Systolic Blood Pressure
Primary Effectiveness Outcome Measure
Measured: Baseline to 6 months post-randomization
Secondary outcomes (1)
Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2013
- Study completion17 Feb 2017
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 Uncontrolled 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Bakris, MD, Principal investigator, Professor of Medicine, Hypertension Center Director University of Chicago Medical CenterDeepak L Bhatt, MD, MPH, Principal investigator, VA Boston Healthcare System Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418261
- Sponsor's protocol ID
- IP125
- Status last verified
- Apr 2017
- First submitted
- 15 Aug 2011
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bhatt DL, Vaduganathan M, Kandzari DE, Leon MB, Rocha-Singh K, Townsend RR, Katzen BT, Oparil S, Brar S, DeBruin V, Fahy M, Bakris GL; SYMPLICITY HTN-3 Steering Committee Investigators. Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial. Lancet. 2022 Oct 22;400(10361):1405-1416. doi: 10.1016/S0140-6736(22)01787-1. Epub 2022 Sep 18.
PubMed 36130612Mahfoud F, Bakris G, Bhatt DL, Esler M, Ewen S, Fahy M, Kandzari D, Kario K, Mancia G, Weber M, Bohm M. Reduced blood pressure-lowering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. Eur Heart J. 2017 Jan 7;38(2):93-100. doi: 10.1093/eurheartj/ehw325.
PubMed 28158510Pocock SJ, Bakris G, Bhatt DL, Brar S, Fahy M, Gersh BJ. Regression to the Mean in SYMPLICITY HTN-3: Implications for Design and Reporting of Future Trials. J Am Coll Cardiol. 2016 Nov 1;68(18):2016-2025. doi: 10.1016/j.jacc.2016.07.775.
PubMed 27788856Kario K, Bhatt DL, Brar S, Cohen SA, Fahy M, Bakris GL. Effect of Catheter-Based Renal Denervation on Morning and Nocturnal Blood Pressure: Insights From SYMPLICITY HTN-3 and SYMPLICITY HTN-Japan. Hypertension. 2015 Dec;66(6):1130-7. doi: 10.1161/HYPERTENSIONAHA.115.06260. Epub 2015 Oct 5.
PubMed 26558819Bakris GL, Townsend RR, Flack JM, Brar S, Cohen SA, D'Agostino R, Kandzari DE, Katzen BT, Leon MB, Mauri L, Negoita M, O'Neill WW, Oparil S, Rocha-Singh K, Bhatt DL; SYMPLICITY HTN-3 Investigators. 12-month blood pressure results of catheter-based renal artery denervation for resistant hypertension: the SYMPLICITY HTN-3 trial. J Am Coll Cardiol. 2015 Apr 7;65(13):1314-1321. doi: 10.1016/j.jacc.2015.01.037.
PubMed 25835443Kandzari DE, Bhatt DL, Brar S, Devireddy CM, Esler M, Fahy M, Flack JM, Katzen BT, Lea J, Lee DP, Leon MB, Ma A, Massaro J, Mauri L, Oparil S, O'Neill WW, Patel MR, Rocha-Singh K, Sobotka PA, Svetkey L, Townsend RR, Bakris GL. Predictors of blood pressure response in the SYMPLICITY HTN-3 trial. Eur Heart J. 2015 Jan 21;36(4):219-27. doi: 10.1093/eurheartj/ehu441. Epub 2014 Nov 16.
PubMed 25400162Bakris GL, Townsend RR, Liu M, Cohen SA, D'Agostino R, Flack JM, Kandzari DE, Katzen BT, Leon MB, Mauri L, Negoita M, O'Neill WW, Oparil S, Rocha-Singh K, Bhatt DL; SYMPLICITY HTN-3 Investigators. Impact of renal denervation on 24-hour ambulatory blood pressure: results from SYMPLICITY HTN-3. J Am Coll Cardiol. 2014 Sep 16;64(11):1071-8. doi: 10.1016/j.jacc.2014.05.012. Epub 2014 May 20.
PubMed 24858423Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.
PubMed 24678939
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)
- ClinicalTrials.gov ID
- NCT01418261
- Acronym / sponsor ID
- IP125
- Conditions
- Uncontrolled Hypertension
- Keywords
- uncontrolled hypertension, renal denervation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- 17 Feb 2017 (actual)
- First posted
- 17 Aug 2011 (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 Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.
Detailed description
The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation | Experimental | Device: Renal denervation (Symplicity Catheter System), Diagnostic Test: Renal angiogramSubjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications |
| Control group | Sham comparator | Diagnostic Test: Renal angiogramSubjects go through renal angiogram and Subjects maintained baseline anti-hypertensive medications |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individual is ≥ 18 and ≤ 80 years old at time of randomization.
- Individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 2 weeks prior to screening) that is expected to be maintained without changes for at least 6 months.
- Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit
Key exclusion criteria (6 listed)
- Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
- Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP < 135 mmHg
- Individual has type 1 diabetes mellitus
- Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
- Individual has primary pulmonary hypertension.
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 |
|---|---|---|
| Renal denervation (Symplicity Catheter System) | Device | Renal Denervation |
| Renal angiogram | Diagnostic test | Control group, Renal Denervation |
Primary outcome
Change in Office Systolic Blood Pressure
Time frame: Baseline to 6 months post-randomization
Primary Effectiveness Outcome Measure
1 secondary outcome
Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring
Time frame: Baseline to 6 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 26 Apr 2017.
- Derived from this study: PubMed 36130612Bhatt DL, Vaduganathan M, Kandzari DE, Leon MB, Rocha-Singh K, Townsend RR, Katzen BT, Oparil S, Brar S, DeBruin V, Fahy M, Bakris GL; SYMPLICITY HTN-3 Steering Committee Investigators. Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial. Lancet. 2022 Oct 22;400(10361):1405-1416. doi: 10.1016/S0140-6736(22)01787-1. Epub 2022 Sep 18.
- Derived from this study: PubMed 28158510Mahfoud F, Bakris G, Bhatt DL, Esler M, Ewen S, Fahy M, Kandzari D, Kario K, Mancia G, Weber M, Bohm M. Reduced blood pressure-lowering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. Eur Heart J. 2017 Jan 7;38(2):93-100. doi: 10.1093/eurheartj/ehw325.
- Derived from this study: PubMed 27788856Pocock SJ, Bakris G, Bhatt DL, Brar S, Fahy M, Gersh BJ. Regression to the Mean in SYMPLICITY HTN-3: Implications for Design and Reporting of Future Trials. J Am Coll Cardiol. 2016 Nov 1;68(18):2016-2025. doi: 10.1016/j.jacc.2016.07.775.
- Derived from this study: PubMed 26558819Kario K, Bhatt DL, Brar S, Cohen SA, Fahy M, Bakris GL. Effect of Catheter-Based Renal Denervation on Morning and Nocturnal Blood Pressure: Insights From SYMPLICITY HTN-3 and SYMPLICITY HTN-Japan. Hypertension. 2015 Dec;66(6):1130-7. doi: 10.1161/HYPERTENSIONAHA.115.06260. Epub 2015 Oct 5.
- Derived from this study: PubMed 25835443Bakris GL, Townsend RR, Flack JM, Brar S, Cohen SA, D'Agostino R, Kandzari DE, Katzen BT, Leon MB, Mauri L, Negoita M, O'Neill WW, Oparil S, Rocha-Singh K, Bhatt DL; SYMPLICITY HTN-3 Investigators. 12-month blood pressure results of catheter-based renal artery denervation for resistant hypertension: the SYMPLICITY HTN-3 trial. J Am Coll Cardiol. 2015 Apr 7;65(13):1314-1321. doi: 10.1016/j.jacc.2015.01.037.
- Derived from this study: PubMed 25400162Kandzari DE, Bhatt DL, Brar S, Devireddy CM, Esler M, Fahy M, Flack JM, Katzen BT, Lea J, Lee DP, Leon MB, Ma A, Massaro J, Mauri L, Oparil S, O'Neill WW, Patel MR, Rocha-Singh K, Sobotka PA, Svetkey L, Townsend RR, Bakris GL. Predictors of blood pressure response in the SYMPLICITY HTN-3 trial. Eur Heart J. 2015 Jan 21;36(4):219-27. doi: 10.1093/eurheartj/ehu441. Epub 2014 Nov 16.
- Derived from this study: PubMed 24858423Bakris GL, Townsend RR, Liu M, Cohen SA, D'Agostino R, Flack JM, Kandzari DE, Katzen BT, Leon MB, Mauri L, Negoita M, O'Neill WW, Oparil S, Rocha-Singh K, Bhatt DL; SYMPLICITY HTN-3 Investigators. Impact of renal denervation on 24-hour ambulatory blood pressure: results from SYMPLICITY HTN-3. J Am Coll Cardiol. 2014 Sep 16;64(11):1071-8. doi: 10.1016/j.jacc.2014.05.012. Epub 2014 May 20.
- Derived from this study: PubMed 24678939Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.
- Individual participant dataSharing planned: No
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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.
George Bakris, MD principal investigator
Professor of Medicine, Hypertension Center Director University of Chicago Medical Center
Deepak L Bhatt, MD, MPH principal investigator
VA Boston Healthcare System Department of Cardiology
79 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal denervation (Symplicity Catheter System) and Renal angiogram in people with Uncontrolled Hypertension, run by Medtronic Vascular at 79 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 6 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 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 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.
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?
Change in Office Systolic Blood Pressure (time frame: Baseline to 6 months post-randomization). 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 NCT01418261, 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 26 Apr 2017.