Cardiovascular DiseasesPhase 3NCT00000516
Studies of Left Ventricular Dysfunction (SOLVD)
A Phase 3 study testing enalapril in people with Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine if enalapril treatment of left ventricular dysfunction (LVD) due to ischemic or hypertensive heart disease led to reduced mortality and morbidity in symptomatic and asymptomatic patients. There were a Prevention Trial, a Treatment Trial, and a registry. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- What is being tested?
- enalapril
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1985to May 1990
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Men and women, ages 21 to 80. Subjects were asymptomatic or symptomatic and had ejection fractions equal to or below 35 percent.
About this study
To determine if enalapril treatment of left ventricular dysfunction (LVD) due to ischemic or hypertensive heart disease led to reduced mortality and morbidity in symptomatic and asymptomatic patients. There were a Prevention Trial, a Treatment Trial, and a registry.
Read the detailed description
BACKGROUND:
Approximately two million Americans suffer from heart failure. Since the prevalence of congestive heart failure is known to increase with age, improvements in the average life expectancy would be expected to increase the magnitude of the problem over the next few decades. While advances in the treatment of hypertension, coronary artery disease, and surgical treatment of congenital and valvular heart disease have prolonged survival, many of these patients ultimately develop heart failure in later life.
The therapy of congestive heart failure has undergone rapid change. Until the early 1970s, the mainstay of therapy for the patient with acute and chronic congestive heart failure was digitalis and diuretics. The use of digitalis in patients with heart failure secondary to ischemic heart disease and in those with severe left ventricular failure of either nonischemic or ischemic origin was, however, controversial.
Controversy over the acute and long-term effects of digitalis led to the introduction of a variety of alternative and supplemental therapeutic approaches for the patient with heart failure. In the mid 1980s, a wide spectrum of vasodilators was available. New, at that time, inotropic agents, also found applications as alternatives or supplements to digitalis administration. Although all of these drugs had been shown to be of some benefit in the management of patients with chronic heart failure, there was inadequate information as to the long-term hemodynamic effects of some of these agents and practically no information regarding their effect on survival.
The recognition that patients with congestive heart failure often have elevated peripheral vascular resistance led to the introduction of vasodilator therapy. Of the vasodilators, the angiotensin-converting enzyme (ACE) inhibitors appeared to be the most promising because they had been shown to counteract some of the major adverse hormonal and vasoconstrictor mechanisms, relieve symptoms, diminish cardiac dilatation after myocardial infarction, and improve exercise capacity and ejection fraction.
SOLVD was initiated in 1986 primarily to evaluate the effects of enalapril, an angiotensin-converting enzyme (ACE) inhibitor. Two considerations influenced the design of SOLVD: it was possible that drug treatment given to patients who already had manifest congestive heart failure might not be as beneficial as initiating treatment in asymptomatic left ventricular dysfunction patients; early treatment of such asymptomatic patients might be less beneficial, as the patient might not have measurable activation of the renin-angiotensin axis.
The Request for Proposals was released in August 1984 with the first awards made in July 1985. A second Request for Proposals for additional clinical centers was released in March 1985.
DESIGN NARRATIVE:
Both trials were randomized and double-blind. Prior to randomization, all patients received enalapril, and placebo for two weeks to enable early detection of non-compliant patients, those unable to tolerate the drug, and those with early side-effects. After completion of the pre-randomization period, participants were allocated to enalapril or placebo using a permuted block randomization within each of the clinical centers. Follow-up visits were scheduled for two and six weeks after randomization and then at four, eight, and twelve months. Thereafter, clinic visits were scheduled at four-month intervals. Patients were followed for a minimum of two years and a maximum of five years. Primary outcome for each trial was all-cause mortality. Secondary endpoints included cardiovascular mortality, sudden death due to worsening congestive heart failure, hospitalization for congestive heart failure, myocardial infarction, stroke, need for cardiac transplantation, and quality of life. Onset of congestive heart failure was an additional outcome in the Prevention Trial. Seven substudies were conducted among subsets of participants and included: diastolic function; echocardiography; exercise; neurohumoral; quality of life; radionuclide; sudden death. Patient recruitment began in July 1986. Recruitment in the Treatment Trial ended six months ahead of schedule in February 1989, and follow-up ended in February 1991. The Prevention Trial ended recruitment in April 1990 and completed follow-up in July 1991. Data analysis continued through November 1994.
The trial also included a registry which enrolled 6,300 patients to study the influence of a number of patient characteristics on mortality. Eighteen of the clinical centers participated. Data were collected from consecutive patients with ejection fraction less than .45 or with radiologic evidence of congestive heart failure over a twelve month period. At one year, patient's vital status was ascertained by mail and, if necessary, by telephone follow-up. One year follow-up was completed on all registry patients by May 1990. Longer term follow-up was done through the National Death Index.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Heart Failure, Hypertension, Myocardial Ischemia
- Being tested
- enalapril
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Heart Failure, Hypertension, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enalaprilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startJul 1985
- Study completionMay 1990
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (55)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Clarence Davis, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000516
- Sponsor's protocol ID
- 35
- Status last verified
- Apr 2012
- First submitted
- 27 Oct 1999
- Last updated
- 15 Apr 2016
- Results posted
- No
Publications
Konstam MA, Kronenberg MW, Udelson JE, Metherall J, Dolan N, Edens TR, Howe DM, Yusuf S, Youngblood M, Toltsis H. Effect of acute angiotensin converting enzyme inhibition on left ventricular filling in patients with congestive heart failure. Relation to right ventricular volumes. Circulation. 1990 Feb;81(2 Suppl):III115-22.
PubMed 2153478Studies of left ventricular dysfunction (SOLVD)--rationale, design and methods: two trials that evaluate the effect of enalapril in patients with reduced ejection fraction. Am J Cardiol. 1990 Aug 1;66(3):315-22. doi: 10.1016/0002-9149(90)90842-o.
PubMed 2195865Francis GS, Benedict C, Johnstone DE, Kirlin PC, Nicklas J, Liang CS, Kubo SH, Rudin-Toretsky E, Yusuf S. Comparison of neuroendocrine activation in patients with left ventricular dysfunction with and without congestive heart failure. A substudy of the Studies of Left Ventricular Dysfunction (SOLVD). Circulation. 1990 Nov;82(5):1724-9. doi: 10.1161/01.cir.82.5.1724.
PubMed 2146040SOLVD Investigators; Yusuf S, Pitt B, Davis CE, Hood WB, Cohn JN. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med. 1991 Aug 1;325(5):293-302. doi: 10.1056/NEJM199108013250501.
PubMed 2057034Hood WB Jr, Youngblood M, Ghali JK, Reid M, Rogers WJ, Howe D, Teo KK, LeJemtel TH. Initial blood pressure response to enalapril in hospitalized patients (Studies of Left Ventricular Dysfunction [SOLVD]). Am J Cardiol. 1991 Dec 1;68(15):1465-8. doi: 10.1016/0002-9149(91)90280-x.
PubMed 1746428SOLVD Investigators; Yusuf S, Pitt B, Davis CE, Hood WB Jr, Cohn JN. Effect of enalapril on mortality and the development of heart failure in asymptomatic patients with reduced left ventricular ejection fractions. N Engl J Med. 1992 Sep 3;327(10):685-91. doi: 10.1056/NEJM199209033271003.
PubMed 1463530Konstam MA, Rousseau MF, Kronenberg MW, Udelson JE, Melin J, Stewart D, Dolan N, Edens TR, Ahn S, Kinan D, et al. Effects of the angiotensin converting enzyme inhibitor enalapril on the long-term progression of left ventricular dysfunction in patients with heart failure. SOLVD Investigators. Circulation. 1992 Aug;86(2):431-8. doi: 10.1161/01.cir.86.2.431.
PubMed 1638712Liang CS, Stewart DK, LeJemtel TH, Kirlin PC, McIntyre KM, Robertson HT, Brown R, Moore AW, Wellington KL, Cahill L, et al. Characteristics of peak aerobic capacity in symptomatic and asymptomatic subjects with left ventricular dysfunction. The Studies of Left Ventricular Dysfunction (SOLVD) Investigators. Am J Cardiol. 1992 May 1;69(14):1207-11. doi: 10.1016/0002-9149(92)90937-t.
PubMed 1575192Konstam MA, Kronenberg MW, Udelson JE, Kinan D, Metherall J, Dolan N, Edens T, Howe D, Kilcoyne L, Benedict C, et al. Effectiveness of preload reserve as a determinant of clinical status in patients with left ventricular systolic dysfunction. The SOLVD Investigators. Am J Cardiol. 1992 Jun 15;69(19):1591-5. doi: 10.1016/0002-9149(92)90709-8.
PubMed 1598875Carew BD, Ahn SA, Boichot HD, Dierenfeldt BJ, Dolan NA, Edens TR, Weiner DH, Probstfield JL. Recruitment strategies in the studies of left ventricular dysfunction (SOLVD): strategies for screening and enrollment in two concurrent but separate trials. The SOLVD Investigators. Control Clin Trials. 1992 Oct;13(5):325-38. doi: 10.1016/0197-2456(92)90035-x.
PubMed 1330437Johnstone D, Limacher M, Rousseau M, Liang CS, Ekelund L, Herman M, Stewart D, Guillotte M, Bjerken G, Gaasch W, et al. Clinical characteristics of patients in studies of left ventricular dysfunction (SOLVD). Am J Cardiol. 1992 Oct 1;70(9):894-900. doi: 10.1016/0002-9149(92)90734-g.
PubMed 1529944Pouleur H. Results of the treatment trial of the studies of left ventricular dysfunction (SOLVD). The SOLVD Investigators. Am J Cardiol. 1992 Oct 8;70(10):135C-136C. doi: 10.1016/0002-9149(92)91372-b. No abstract available.
PubMed 1414890Bangdiwala SI, Weiner DH, Bourassa MG, Friesinger GC 2nd, Ghali JK, Yusuf S. Studies of Left Ventricular Dysfunction (SOLVD) Registry: rationale, design, methods and description of baseline characteristics. Am J Cardiol. 1992 Aug 1;70(3):347-53. doi: 10.1016/0002-9149(92)90617-8.
PubMed 1632401Pouleur H, Rousseau MF, van Eyll C, Stoleru L, Hayashida W, Udelson JA, Dolan N, Kinan D, Gallagher P, Ahn S, et al. Effects of long-term enalapril therapy on left ventricular diastolic properties in patients with depressed ejection fraction. SOLVD Investigators. Circulation. 1993 Aug;88(2):481-91. doi: 10.1161/01.cir.88.2.481.
PubMed 8101772Gorkin L, Norvell NK, Rosen RC, Charles E, Shumaker SA, McIntyre KM, Capone RJ, Kostis J, Niaura R, Woods P, et al. Assessment of quality of life as observed from the baseline data of the Studies of Left Ventricular Dysfunction (SOLVD) trial quality-of-life substudy. Am J Cardiol. 1993 May 1;71(12):1069-73. doi: 10.1016/0002-9149(93)90575-w.
PubMed 8475871
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Left Ventricular Dysfunction (SOLVD)
- ClinicalTrials.gov ID
- NCT00000516
- Acronym / sponsor ID
- 35
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Heart Failure, Hypertension, Myocardial Ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1985
- Study completion
- May 1990 (actual)
- First posted
- 28 Oct 1999 (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.
To determine if enalapril treatment of left ventricular dysfunction (LVD) due to ischemic or hypertensive heart disease led to reduced mortality and morbidity in symptomatic and asymptomatic patients. There were a Prevention Trial, a Treatment Trial, and a registry.
Detailed description
BACKGROUND:
Approximately two million Americans suffer from heart failure. Since the prevalence of congestive heart failure is known to increase with age, improvements in the average life expectancy would be expected to increase the magnitude of the problem over the next few decades. While advances in the treatment of hypertension, coronary artery disease, and surgical treatment of congenital and valvular heart disease have prolonged survival, many of these patients ultimately develop heart failure in later life.
The therapy of congestive heart failure has undergone rapid change. Until the early 1970s, the mainstay of therapy for the patient with acute and chronic congestive heart failure was digitalis and diuretics. The use of digitalis in patients with heart failure secondary to ischemic heart disease and in those with severe left ventricular failure of either nonischemic or ischemic origin was, however, controversial.
Controversy over the acute and long-term effects of digitalis led to the introduction of a variety of alternative and supplemental therapeutic approaches for the patient with heart failure. In the mid 1980s, a wide spectrum of vasodilators was available. New, at that time, inotropic agents, also found applications as alternatives or supplements to digitalis administration. Although all of these drugs had been shown to be of some benefit in the management of patients with chronic heart failure, there was inadequate information as to the long-term hemodynamic effects of some of these agents and practically no information regarding their effect on survival.
The recognition that patients with congestive heart failure often have elevated peripheral vascular resistance led to the introduction of vasodilator therapy. Of the vasodilators, the angiotensin-converting enzyme (ACE) inhibitors appeared to be the most promising because they had been shown to counteract some of the major adverse hormonal and vasoconstrictor mechanisms, relieve symptoms, diminish cardiac dilatation after myocardial infarction, and improve exercise capacity and ejection fraction.
SOLVD was initiated in 1986 primarily to evaluate the effects of enalapril, an angiotensin-converting enzyme (ACE) inhibitor. Two considerations influenced the design of SOLVD: it was possible that drug treatment given to patients who already had manifest congestive heart failure might not be as beneficial as initiating treatment in asymptomatic left ventricular dysfunction patients; early treatment of such asymptomatic patients might be less beneficial, as the patient might not have measurable activation of the renin-angiotensin axis.
The Request for Proposals was released in August 1984 with the first awards made in July 1985. A second Request for Proposals for additional clinical centers was released in March 1985.
DESIGN NARRATIVE:
Both trials were randomized and double-blind. Prior to randomization, all patients received enalapril, and placebo for two weeks to enable early detection of non-compliant patients, those unable to tolerate the drug, and those with early side-effects. After completion of the pre-randomization period, participants were allocated to enalapril or placebo using a permuted block randomization within each of the clinical centers. Follow-up visits were scheduled for two and six weeks after randomization and then at four, eight, and twelve months. Thereafter, clinic visits were scheduled at four-month intervals. Patients were followed for a minimum of two years and a maximum of five years. Primary outcome for each trial was all-cause mortality. Secondary endpoints included cardiovascular mortality, sudden death due to worsening congestive heart failure, hospitalization for congestive heart failure, myocardial infarction, stroke, need for cardiac transplantation, and quality of life. Onset of congestive heart failure was an additional outcome in the Prevention Trial. Seven substudies were conducted among subsets of participants and included: diastolic function; echocardiography; exercise; neurohumoral; quality of life; radionuclide; sudden death. Patient recruitment began in July 1986. Recruitment in the Treatment Trial ended six months ahead of schedule in February 1989, and follow-up ended in February 1991. The Prevention Trial ended recruitment in April 1990 and completed follow-up in July 1991. Data analysis continued through November 1994.
The trial also included a registry which enrolled 6,300 patients to study the influence of a number of patient characteristics on mortality. Eighteen of the clinical centers participated. Data were collected from consecutive patients with ejection fraction less than .45 or with radiologic evidence of congestive heart failure over a twelve month period. At one year, patient's vital status was ascertained by mail and, if necessary, by telephone follow-up. One year follow-up was completed on all registry patients by May 1990. Longer term follow-up was done through the National Death Index.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| enalapril | Drug | – |
Primary outcome
Not reported in the source record.
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 15 Apr 2016.
- Background: PubMed 2153478Konstam MA, Kronenberg MW, Udelson JE, Metherall J, Dolan N, Edens TR, Howe DM, Yusuf S, Youngblood M, Toltsis H. Effect of acute angiotensin converting enzyme inhibition on left ventricular filling in patients with congestive heart failure. Relation to right ventricular volumes. Circulation. 1990 Feb;81(2 Suppl):III115-22.
- Background: PubMed 2195865Studies of left ventricular dysfunction (SOLVD)--rationale, design and methods: two trials that evaluate the effect of enalapril in patients with reduced ejection fraction. Am J Cardiol. 1990 Aug 1;66(3):315-22. doi: 10.1016/0002-9149(90)90842-o.
- Background: PubMed 2146040Francis GS, Benedict C, Johnstone DE, Kirlin PC, Nicklas J, Liang CS, Kubo SH, Rudin-Toretsky E, Yusuf S. Comparison of neuroendocrine activation in patients with left ventricular dysfunction with and without congestive heart failure. A substudy of the Studies of Left Ventricular Dysfunction (SOLVD). Circulation. 1990 Nov;82(5):1724-9. doi: 10.1161/01.cir.82.5.1724.
- Background: PubMed 2057034SOLVD Investigators; Yusuf S, Pitt B, Davis CE, Hood WB, Cohn JN. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med. 1991 Aug 1;325(5):293-302. doi: 10.1056/NEJM199108013250501.
- Background: PubMed 1746428Hood WB Jr, Youngblood M, Ghali JK, Reid M, Rogers WJ, Howe D, Teo KK, LeJemtel TH. Initial blood pressure response to enalapril in hospitalized patients (Studies of Left Ventricular Dysfunction [SOLVD]). Am J Cardiol. 1991 Dec 1;68(15):1465-8. doi: 10.1016/0002-9149(91)90280-x.
- Background: PubMed 1463530SOLVD Investigators; Yusuf S, Pitt B, Davis CE, Hood WB Jr, Cohn JN. Effect of enalapril on mortality and the development of heart failure in asymptomatic patients with reduced left ventricular ejection fractions. N Engl J Med. 1992 Sep 3;327(10):685-91. doi: 10.1056/NEJM199209033271003.
- Background: PubMed 1638712Konstam MA, Rousseau MF, Kronenberg MW, Udelson JE, Melin J, Stewart D, Dolan N, Edens TR, Ahn S, Kinan D, et al. Effects of the angiotensin converting enzyme inhibitor enalapril on the long-term progression of left ventricular dysfunction in patients with heart failure. SOLVD Investigators. Circulation. 1992 Aug;86(2):431-8. doi: 10.1161/01.cir.86.2.431.
- Background: PubMed 1575192Liang CS, Stewart DK, LeJemtel TH, Kirlin PC, McIntyre KM, Robertson HT, Brown R, Moore AW, Wellington KL, Cahill L, et al. Characteristics of peak aerobic capacity in symptomatic and asymptomatic subjects with left ventricular dysfunction. The Studies of Left Ventricular Dysfunction (SOLVD) Investigators. Am J Cardiol. 1992 May 1;69(14):1207-11. doi: 10.1016/0002-9149(92)90937-t.
- Background: PubMed 1598875Konstam MA, Kronenberg MW, Udelson JE, Kinan D, Metherall J, Dolan N, Edens T, Howe D, Kilcoyne L, Benedict C, et al. Effectiveness of preload reserve as a determinant of clinical status in patients with left ventricular systolic dysfunction. The SOLVD Investigators. Am J Cardiol. 1992 Jun 15;69(19):1591-5. doi: 10.1016/0002-9149(92)90709-8.
- Background: PubMed 1330437Carew BD, Ahn SA, Boichot HD, Dierenfeldt BJ, Dolan NA, Edens TR, Weiner DH, Probstfield JL. Recruitment strategies in the studies of left ventricular dysfunction (SOLVD): strategies for screening and enrollment in two concurrent but separate trials. The SOLVD Investigators. Control Clin Trials. 1992 Oct;13(5):325-38. doi: 10.1016/0197-2456(92)90035-x.
- Background: PubMed 1529944Johnstone D, Limacher M, Rousseau M, Liang CS, Ekelund L, Herman M, Stewart D, Guillotte M, Bjerken G, Gaasch W, et al. Clinical characteristics of patients in studies of left ventricular dysfunction (SOLVD). Am J Cardiol. 1992 Oct 1;70(9):894-900. doi: 10.1016/0002-9149(92)90734-g.
- Background: PubMed 1414890Pouleur H. Results of the treatment trial of the studies of left ventricular dysfunction (SOLVD). The SOLVD Investigators. Am J Cardiol. 1992 Oct 8;70(10):135C-136C. doi: 10.1016/0002-9149(92)91372-b. No abstract available.
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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.
Clarence Davis
University of North Carolina
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing enalapril in people with Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000516, which also lists 55 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 15 Apr 2016; AzTrials last refreshed its copy on 2 Nov 2026.