This Will be a Randomized Comparison of the Proteomic Effects of Vicadrostat/Empagliflozin Versus Empagliflozin and Versus Empagliflozin/Spironolactone in Heart Failure Patients With Preserved Ejection Fraction (SPECTRA-HFpEF)

September 29, 2026 updated by: Baim Institute for Clinical Research

A Randomized Comparison of the Proteomic Effects of Vicadrostat/Empagliflozin Versus Empagliflozin and Versus Empagliflozin/Spironolactone in Heart Failure Patients With Preserved Ejection Fraction

The SPECTRA-HFpEF Study is a randomized, double-blind, Phase 2 clinical study designed to evaluate and compare the biological effects of vicadrostat in combination with empagliflozin, empagliflozin alone, and spironolactone in combination with empagliflozin in adults with heart failure and preserved ejection fraction. The study will enroll approximately 200 participants with chronic heart failure, New York Heart Association Class II to IV symptoms, and left ventricular ejection fraction greater than 40%. The primary objective is to determine whether treatment with vicadrostat/empagliflozin produces differential changes in circulating plasma proteins compared with spironolactone/empagliflozin, using a broad proteomic panel measured over the course of treatment. These proteomic changes may help identify biological pathways affected by each treatment strategy, including pathways related to inflammation, myocardial fibrosis and remodeling, kidney function, cardiac stress, and aldosterone-related signaling.

Participants will complete an approximately 26-week study period, including screening, treatment, and follow-up phases. After screening and any required washout of prior sodium-glucose cotransporter 2 inhibitor therapy, participants will receive open-label empagliflozin and will be randomized in a blinded manner to receive vicadrostat or placebo during the first treatment period. During the second treatment period, participants will receive either continued vicadrostat with empagliflozin or spironolactone with empagliflozin. During the third treatment period, vicadrostat or spironolactone will be discontinued while empagliflozin is continued. Blood and urine samples will be collected at specified visits to evaluate changes in proteomic markers, renin-angiotensin-aldosterone system biomarkers, collagen turnover markers, sex hormone markers, kidney function, proteinuria, inflammatory biomarkers, and cardiac stress biomarkers. Echocardiography and patient-reported health status assessments will also be performed to explore potential effects on cardiac structure, function, symptoms, and quality of life.

The study is intended to improve understanding of how aldosterone synthase inhibition with vicadrostat differs from mineralocorticoid receptor antagonism with spironolactone when each is used with empagliflozin in patients with heart failure and preserved ejection fraction. By comparing treatment-related proteomic and biomarker changes across study arms, the study may provide insight into mechanistic differences between these therapeutic approaches and help inform future development of targeted combination therapies for heart failure. Safety and tolerability will be monitored throughout the study through collection of adverse events, serious adverse events, vital signs, electrocardiograms, physical examinations, and clinical laboratory assessments, including kidney function and serum potassium monitoring.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This double-blind, randomized, Phase 2 study is being conducted in adult participants with heart failure (HF) and left ventricular ejection fraction (LVEF) >40% to primarily assess the impact of vicadrostat/empagliflozin (vica/empa) versus placebo/empa and versus spironolactone (spiro)/empa on the proteome.

The study includes 4 discrete study periods. All doses will be given once daily (QD) during the Treatment Periods. Empa will be given open-label.

  • Screening: 4 week duration including a 2-week washout period of SGLT2 inhibitors

  • Treatment Period 1: participants will be given open-label empa 10 mg QD and randomized to vica 10 mg QD versus placebo QD (8 weeks)

  • Treatment Period 2: vica 10 mg QD/empa 10 mg QD versus spiro 25-50 mg QD/empa 10 mg QD (10 weeks)

    • Participants randomized to vica in Treatment Period 1 will continue treatment and remain blinded.
    • Participants randomized to placebo in Treatment Period 1 will be given blinded spiro/empa.

  • Treatment Period 3:

    • Discontinuation of vica or spiro.
    • Continuation of open-label empa in both treatment arms.

The main questions for the analysis include:

  • The relative change in plasma concentration of a pre-specified panel of 5400 proteins measured using the Olink Explore HT panel from Study Visit 1 (baseline) through Study Visit 7 (18 weeks), compared between those treated with vica/empa versus spiro/empa
  • The safety profile of using Incidence of TEAEs and SAEs and change from baseline in clinical laboratory values, vital signs, and ECGs.
  • Additional protenomic analyses between the groups
  • Other blood markers/biomarkers

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participant is aged ≥18 years.

  2. Participant provides informed consent to participate in the study in accordance with ICH-GCP and local legislation prior to any study procedures taking place.

  3. Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of <1% per year when used consistently and correctly.

  4. Participant has chronic HF diagnosed ≥3 months before enrollment, and in New York Heart Association (NYHA) class II-IV.

  5. Participant has LVEF >40% in the 12 months prior to enrollment.

  6. N-terminal pro-B type natriuretic peptide (NT-proBNP) must be:

    NT-proBNP level (kg/m²) BMI <27 (kg/m²) BMI ≥27 to <35 BMI ≥35 Without AF or AFL Non-Black participants ≥300 pg/mL ≥200 pg/mL ≥125 pg/mL Black Participants ≥240 pg/mL ≥160 pg/mL ≥100 pg/mL With AF or AFL Non-Black participants ≥600 pg/mL ≥400 pg/mL ≥250 pg/mL Black Participants ≥480 pg/mL ≥320 pg/mL ≥200 pg/mL Abbreviations: AF: atrial fibrillation; AFL: atrial flutter. Note: Race is self-reported.

  7. Participants must have ≥1 of the following:

    1. Currently treated with diuretic therapy (e.g. loop diuretics or thiazides) and on a stable dose for ≥1 week prior to enrollment.

    2. Currently treated with an SGLT2 inhibitor and on a stable dose for at ≥1 week prior to enrollment; those receiving an SGLT2 inhibitor for treatment of diabetes mellitus will be monitored for need of extra glucose lowering treatment by the study investigator in conjunction with the local physician during the washout period per usual care.

    3. Documented hospitalization for HF within 6 months prior to enrollment.

    4. Elevated cardiac filling pressures (e.g. pulmonary capillary wedge pressure ≥15 mm at rest or ≥25 mm with exercise) within 6 months prior to enrollment.

    5. Markedly elevated NT-proBNP

      • In participants without AF/AFL: ≥900 pg/mL
      • In participants with AF/AFL: ≥1800 pg/mL

    6. UACR ≥30 mg/g.

    7. At least 2 echocardiographic cardiac structural changes from the following:

      • Left ventricular hypertrophy
      • E/e' ≥9
      • Left atrial volume index >33 mL/m2

Exclusion Criteria:

  1. Treatment with an MRA (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to enrollment and no intention to initiate MRA during the study.

  2. Treatment with amiloride, direct renin inhibitor (e.g. aliskiren), or the combination of ACEi plus ARB.

  3. Treatment with any other ASi.

  4. Major contraindication to SGLT2 inhibition, including history of Type 1 diabetes or previous ketoacidosis.

  5. eGFR < 20 mL/min/1.73m2 at screening.

  6. Serum potassium >5.2 mmol/L at screening.

  7. Myocardial infarction, cerebrovascular accident, transient ischemic attack, stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery or any other major surgery (per investigator judgement) within 90 days prior to enrollment, or scheduled for major elective surgery (e.g. hip replacement, CABG surgery).

  8. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device.

  9. Known cardiomyopathy due to infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy, or known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to enrollment.

  10. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding enrollment.

  11. Known severe valvular heart disease (obstructive or regurgitant), per investigator judgment, or valvular heart disease scheduled for surgical or invasive procedures at enrollment, or anticipated invasive treatment during the study.

  12. Active or prior cancer of any kind except for non-melanoma skin cancers.

  13. Psychiatric illness, cognitive impairment, behavioral issues, or social situation that in the opinion of the investigator will compromise the participant's ability to comply with study procedures

  14. Participant is pregnant or lactating or plans to become pregnant during the study or up to 2 weeks after the study.

  15. Patient has a known hypersensitivity to any components of the IMPs or any of their excipients that, in the opinion of the investigator, suggests a high risk for a severe hypersensitivity reaction while on treatment.

  16. Any other condition not specified above that in the opinion of the investigator would confound the interpretation of data from the study

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: empa plus vica

Participants randomized to this arm will receive Vica 10 mg and empa 10 mg (in treatment periods 1 and 2) with empa 10 mg (treatment period 3)
Drug: empa plus vica

Participants will be randomized to to this arm will receive empa (open-label)/vica (blinded). In treatment period 1 those randomized to empa/vica will be administered one tablet of empa 10 mg QD and one tablet of vica 10 mg QD for 8 weeks. In treatment period 2 for those randomized to empa/vica will continue to take empa 10 mg QD and vica 10 mg QD plus a placebo-matching spiro for 10 weeks. In treatment period 3, this group will receive open-label empa 10 mg QD for 4 weeks.
Active Comparator: empa plus spironolactone

Participants randomized to this arm will receive empa 10 mg QD and vica matching placebo tablet in treatment period 1; empa 10 mg QD plus spironolactone 25 mg titrating to 50 mg QD in treatment period 2 and empa 10 mg in treatment period 3.
Drug: Comparator: empa 10 plus spironolactone

For those randomized to empa (open-label) spiro (blinded), in treatment period 1 they will be administered one tablet of empa 10 mg QD and vica matching placebo for 8 weeks. In treatment period 2 for those randomized to empa/spiro, they will take empa 10 mg QD, spiro 25 mg titrating to 50 mg QD plus a vica matching placebo tablet for 10 weeks. In treatment period 3, this group will receive open-label empa 10 mg QD for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Differences in the proteomic regulation following Treatment Period 2
Time Frame: 18 weeks

To evaluate the relative change in plasma concentration of a pre-specified panel of 5400 proteins measured using the Olink Explore HT panel from Study Visit 1 (baseline) through Study Visit 7 (18 weeks), compared between those treated with vica/empa versus spiro/empa.
18 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Differences in the proteomic regulation following Treatment Period 1.
Time Frame: 8 weeks

To evaluate the relative change in plasma concentration of a pre-specified panel of 5400 proteins measured using the Olink Explore HT panel from Study Visit 1 (baseline) through Study Visit 4 (8 weeks), compared between those treated with vica/empa versus empa will be evaluated.
8 weeks
Differences in the proteomic regulation following Treatment Period 2
Time Frame: 10 Weeks (8 weeks through 18 weeks)

To evaluate the relative change in plasma concentration of a pre-specified panel of 5400 proteins measured using the Olink Explore HT panel from Visit 4 (8 weeks) through Study 7 (18 weeks), compared between those treated with vica/empa versus empa.
10 Weeks (8 weeks through 18 weeks)
Differences in proteomic regulation following Treatment Period 3.
Time Frame: 4 weeks

To compare the relative change in plasma concentration of a pre-specified panel of 5400 proteins measured using the Olink Explore HT panel from Study Visit 7 (18 weeks) through Study Visit 8 (22 weeks), compared between those treated with vica/empa in Treatment Periods 1 and 3 versus empa alone in Treatment Period 3.
4 weeks
Differences in renin, aldosterone and aldosterone precursors across each Treatment Period.
Time Frame: 22 weeks

To evaluate mean within- participant change in plasma renin activity/concentration, serum aldosterone, and 11-deoxycorticosterone from the beginning and end of each Treatment Period, compared across treatment arms.
22 weeks
Differences in markers of collagen synthesis, degradation and cross-linking across each Treatment Period.
Time Frame: 22 weeks

To evaluate mean within- participant change in plasma PICP, CITP, MMP1, PIIINP, and Pro-C6 from the beginning and end of each Treatment Period, compared across treatment arms.
22 weeks
Differences in plasma progesterone across each Treatment Period.
Time Frame: 22 weeks

To evaluate mean within-participant change in plasma progesterone and from the beginning and end of each Treatment Period, compared across treatment arms. This is measured in ng/mL
22 weeks
Differences in measures of kidney function and proteinuria across each Treatment Period.
Time Frame: 22 weeks

To evaluate mean within-participant change in eGFR and UACR from the beginning and end of each Treatment Period, compared across treatment arms
22 weeks
Differences in inflammation across each Treatment Period.
Time Frame: 22 weeks

To evaluate mean within- participant change in plasma NT-proBNP and hs-cTnT from the beginning and end of each Treatment Period, compared across treatment arms.
22 weeks
Differences in plasma testosterone across each Treatment Period
Time Frame: 22 weeks

To evaluate mean within-participant change in plasma testosterone from the beginning and end of each Treatment Period, compared across treatment arms. This will be measured in ng/mL
22 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Differences in safety and tolerability between treatment groups (vica/empa; placebo/empa; and spiro/empa)
Time Frame: 22 weeks

To evaluate Incidence of TEAEs and SAEs
22 weeks
Differences in safety and tolerability between vica/empa and placebo/empa across Treatment Period 1
Time Frame: 8 weeks

To evaluate change from baseline in clinical laboratory values (serum potassium) with the unit of measure mEq/L
8 weeks
Differences in safety and tolerability between vica/empa and placebo/empa across Treatment Period 1.
Time Frame: 8 weeks

To evaluate change from baseline in clinical laboratory values (serum creatinine) measured in mg/dL
8 weeks
Differences in safety and tolerability between vica/empa and placebo/empa across Treatment Period 1.
Time Frame: 8 weeks

To evaluate change from baseline in blood pressure measured in mm/Hg
8 weeks
Differences in safety and tolerability between vica/empa and placebo/empa across Treatment Period 1.
Time Frame: 8 weeks

To evaluate change from baseline in heart rate measured in bpm units
8 weeks
Differences in safety and tolerability between vica/empa and placebo/empa across Treatment Period 1.
Time Frame: 8 weeks

To evaluate change from baseline in QT (measured via 12-lead ECG) measured in milliseconds (ms)
8 weeks
Differences in safety and tolerability between vica/empa and spiro/empa from the beginning of Treatment Period 1 until the end Treatment Period 2
Time Frame: 18 weeks

To evaluate change from beginning of Treatment Period 1 until the end of Treatment Period 2 in clinical laboratory values (serum creatinine) measured in mg/dL
18 weeks
Differences in safety and tolerability between vica/empa and spiro/empa from the beginning of Treatment Period 1 until the end Treatment Period 2
Time Frame: 18 weeks

To evaluate change from beginning of Treatment Period 1 until the end of Treatment Period 2 in clinical laboratory values (serum potassium) measured in mEq/L
18 weeks
Differences in safety and tolerability between vica/empa and spiro/empa from the beginning of Treatment Period 1 until the end Treatment Period 2
Time Frame: 18 weeks

To evaluate the change from the beginning of Treatment Period 1 until the end of Treatment Period 2 in blood pressure measured in mm/Hg
18 weeks
Differences in safety and tolerability between vica/empa and spiro/empa from the beginning of Treatment Period 1 until the end Treatment Period 2
Time Frame: 18 weeks

To evaluate the change from beginning of Treatment Period 1 until the end of Treatment Period 2 in heart rate measured in bpm
18 weeks
Differences in safety and tolerability between vica/empa and spiro/empa from the beginning of Treatment Period 1 until the end Treatment Period 2
Time Frame: 18 weeks

To evaluate the change from Treatment Period 1 until the end of Treatment Period 2 in QT measured on 12-lead ECG measured in milliseconds (ms)
18 weeks
Difference in safety and tolerability between study arms across Treatment Period 3.
Time Frame: 4 weeks

To evaluate the difference in clinical laboratory values (serum creatinine) measured in md/dL between study arms across Treatment Period 3.
4 weeks
Differences in Safety and Tolerability between study arms across Treatment Period 3.
Time Frame: 4 weeks

To evaluate the difference in clinical laboratory values (serum potassium) measured in mEq/L between study arms across Treatment Period 3.
4 weeks
Difference in safety and tolerability between study arms across Treatment Period 3.
Time Frame: 4 weeks

To evaluate the difference in blood pressure measured in mmg/Hg between study arms across Treatment Period 3.
4 weeks
Difference in safety and tolerability between study arms across Treatment Period 3.
Time Frame: 4 weeks

To evaluate the difference in heart rate measured in bpm between study arms across Treatment Period 3.
4 weeks
Difference in safety and tolerability between study arms across Treatment Period 3.
Time Frame: 4 weeks

To evaluate the difference in QT by 12-lead ECG measured in milliseconds (ms) between study arms across Treatment Period 3.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baim Institute for Clinical Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James L Januzzi, MD, Baim Institute for Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BICR 2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings