Assessing the Safety and Bioactivity of SG1002 in Heart Failure Patients
NCT ID: NCT02278276
Last Updated: 2015-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2016-04-30
2018-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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0 mg SG1002
Capsules containing 400 mg of placebo will be provided to subjects. Subjects will take two tablets twice each day.
Placebo
400 mg capsules containing placebo
1600 mg SG1002
Capsules containing 400 mg of sodium polysulthionate (SG1002) will be provided to subjects. Subjects will take two tablets twice each day, providing subjects with 1600 mg SG1002 daily.
sodium polysulthionate
Bioavailable composition of α-sulfur
Interventions
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sodium polysulthionate
Bioavailable composition of α-sulfur
Placebo
400 mg capsules containing placebo
Eligibility Criteria
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Inclusion Criteria
* be ambulatory;
* have left ventricular ejection fraction less than 40% within 6 months of screening;
* have heart failure that has been stable for the previous 3 months (defined by no change in baseline therapy or symptoms of heart failure for the previous 3 months)(changes in diuretics are permitted);
* if female, be either post-menopausal or surgically sterilised or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from signing of the informed consent form though to the Final Visit/Early Termination Visit; and
* be willing and able to provide written informed consent.
Exclusion Criteria
* has had any of the following within 3 months prior to screening: myocardial infarction, unstable angina, cerebrovascular accident, percutaneous coronary intervention, open heart surgery, cardiac resynchronisation therapy (CRT) or transient ischaemic attack (TIA);
* has serious cerebrovascular disease in the opinion of the PI;
* is unable to walk without the assistance of another person;
* has primary lung disease that is the major contributor to current symptom status;
* is currently participating in another interventional clinical study, or has participated in one within 30 days prior to screening;
* has an inability to speak English (due to need to administer standardised English-language questionnaires);
* has current symptomatic hypotension (defined as systolic blood pressure (SBP) ≤ 90 mmHg or diastolic blood pressure (DBP) ≤ 40 mmHg);
* has poorly controlled hypertension (defined as SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) despite therapy;
* will have percutaneous coronary intervention or open heart surgery within 3 months of the screening visit;
* has serious liver disease;
* has poorly controlled diabetes (defined as HbA1c \> 10.0 %);
* has hypersensitivity to sulfur or related compounds;
* uses sulfur containing products or supplements, such as dimethyl sulfoxide (DMSO) or methylsulfonylmethane (MSM);
* has renal insufficiency defined as eGFR \< 30 mL/minute/1.73 m2 (Modification of Diet in Renal Disease Study MDRD);
* has a life expectancy of less than 6 months;
* has active malignancy requiring active anti-neoplastic therapy that will, in the opinion of the Investigator, interfere with study treatment or participation. (Stable basal cell skin cancer and cancers being treated solely with hormonal therapy are allowed);
* has evidence of drug or alcohol abuse within the past 3 years;
* has any other chronic illness that may, in the opinion of the Investigator, increase the risks associated with this trial.
35 Years
85 Years
ALL
No
Sponsors
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Sulfagenix Australia Pty Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Tony Giordano, PhD
Role: STUDY_DIRECTOR
Sulfagenix Australia Pty Ltd.
Central Contacts
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Other Identifiers
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Sulfagenix-SG1002-002
Identifier Type: -
Identifier Source: org_study_id