- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01398423
INV-144 Versus Losartan in Hypertension and Type 2 Diabetes Mellitus Patients With Macroalbuminuria
A 12 Week, Phase II Trial of the Safety, Pharmacokinetics, and Efficacy of INV-144 Compared With Losartan Potassium in Patients With Hypertension and Type 2 Diabetes Mellitus With Nephropathy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A multicenter, randomized, double-blind, parallel-group, active-control trial is designed to evaluate the safety and efficacy of INV-144 versus losartan plus placebo co-administered once daily for 12 weeks in subjects who have type 2 diabetes and hypertension with nephropathy as evidenced by albuminuria.
Approximately 92 adult subjects will be enrolled and randomized in a 1:1 ratio to receive either INV-144 or losartan plus placebo once daily for 12 weeks. The goal is to have approximately 80 subjects complete the entire study.
The trial will consist of a 4-week open-label losartan run-in period, a 12-week double-blind active treatment period, and a 4-week safety follow-up period. Efficacy will be evaluated by measurement of UACR, systolic and diastolic blood pressure, and the HOMA-IR ratio. Safety will be monitored throughout the study by evaluation of adverse events (AEs), physical examinations (PEs), clinical laboratory results, vital signs, and electrocardiograms (ECGs).
Blood samples for PK analysis will be obtained in a subset of approximately 22 subjects, at 2 to 4 sites, to ensure that PK data are obtained from a minimum of 9 subjects in each treatment arm.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Garden Grove, California, United States, 92844
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La Mesa, California, United States, 91942
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Northridge, California, United States, 91324
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Riverside, California, United States, 92505
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Tustin, California, United States, 92780
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Florida
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Kissimmee, Florida, United States, 34741
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Miami, Florida, United States, 33015
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Georgia
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Macon, Georgia, United States, 31217
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Tucker, Georgia, United States, 30084
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Maryland
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Reisterstown, Maryland, United States, 21136
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Minnesota
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Brooklyn Center, Minnesota, United States, 55430
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North Carolina
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Cary, North Carolina, United States, 27511
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Greenville, North Carolina, United States, 27834
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New Bern, North Carolina, United States, 28562
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Raleigh, North Carolina, United States, 27610
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South Carolina
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Aiken, South Carolina, United States, 29801
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Texas
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San Antonio, Texas, United States, 78215
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San Antonio, Texas, United States, 78228
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Virginia
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Norfolk, Virginia, United States, 23507
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men or women, 18 to 85 years of age, inclusive.
- Able and willing to understand and provide written informed consent.
Documented hypertension defined by 1 of the following:
Currently treated with antihypertensive medications, or Untreated with a seated systolic blood pressure (mean of 3 readings) between 126 and 180 millimeters of mercury (mm Hg).
Documented type 2 diabetes mellitus defined by 1 of the following:
Currently treated with anti-diabetic medication (oral and/or insulin), or Fasting serum glucose level ≥126 mg/dL.
- Documented nephropathy evidenced by a UACR of 300 to 3000 mg/g.
- Both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age >40 years without menses for ≥2 years) must agree to use 1 of the following forms of reliable contraception:
Abstinence, meaning a total lack of sexual activity, Oral contraceptives ("the pill") or other hormonal contraceptive methods, Intrauterine device, Double-barrier method (diaphragm or condom plus spermicidal cream), or If female, male partner sterilization.
Exclusion Criteria:
- Required use of an ACE inhibitor, ARB, direct renin inhibitor, or aldosterone antagonist other than study drug, while on the study.
- Systolic blood pressure >180 mm Hg (mean of 3 seated readings, 5 minutes apart, using the subject's dominant arm).
- Chronic kidney disease stage 4 or higher defined as an estimated glomerular filtration rate <30 mL/min per 1.73 m2 (abbreviated MDRD equation).
- Hepatic impairment defined by serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>2 x the upper limit of normal.
- Diagnosis of type 1 diabetes or non-diabetic renal disease, including but not limited to renal-artery stenosis, primary glomerular disease, autoimmune renal diseases, etc.
- Severe anemia defined as hemoglobin < 8 g/dL.
- Congestive heart failure with New York Heart Association Class II, III, or IV symptoms.
- Thiamine (Vitamin B1) deficiency or known alcohol abuse within the past year. If alcohol abuse is suspected, subject must have a normal thiamine blood level documented prior to study entry.
- Any radiocontrast-facilitated study within 30 days prior to Study Day 1.
- Cerebrovascular accident within the previous 6 months, or have had a transient ischemic attack within the previous year.
- Pregnant or nursing women; women of childbearing potential must have a negative serum pregnancy test at Screen.
- Known adverse reaction to losartan and/or ALA.
- Participation in another clinical trial or have received an investigational agent for any reason within 30 days of Study Day 1.
- Any other condition that in the opinion of the Investigator, may adversely affect the safety of the subject, the subject's ability to complete the study, or the outcome of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Active control
Losartan potassium (50 mg) plus placebo to match alpha lipoic acid (600 mg)
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Losartan potassium (50 mg) plus placebo to match alpha lipoic acid (600 mg)
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Experimental: INV-144
INV-144 is a combination drug product consisting of losartan potassium (50mg) and alpha lipoic acid (600 mg)
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INV-144 is a combination drug product consisting of losartan potassium (50mg) and alpha lipoic acid (600 mg)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 12 weeks
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Safety will be monitored throughout the study by evaluation of adverse events (AEs), physical examinations (PEs), clinical laboratory results, vital signs, and electrocardiograms (ECGs).
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: 12 weeks
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Efficacy will be evaluated by measurement of UACR, systolic and diastolic blood pressure, and the HOMA-IR ratio.
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: William Schaeffer, InVasc Therapeutics, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INV144-201
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.
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