INV-144 Versus Losartan in Hypertension and Type 2 Diabetes Mellitus Patients With Macroalbuminuria

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, double-blind, active control trial to determine the safety, efficacy and pharmacokinetics of INV-144 versus losartan potassium plus placebo in subjects with hypertension and Type 2 diabetes mellitus with nephropathy as evidenced by albuminuria.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InVasc Therapeutics, Inc.
• Treatments: Losartan; Thioctic Acid

Criteria

Inclusion Criteria:

1. Men or women, 18 to 85 years of age, inclusive.

2. Able and willing to understand and provide written informed consent.

3. 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).

4. 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.

5. Documented nephropathy evidenced by a UACR of 300 to 3000 mg/g.

6. 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:

1. Required use of an ACE inhibitor, ARB, direct renin inhibitor, or aldosterone antagonist other than study drug, while on the study.

2. Systolic blood pressure >180 mm Hg (mean of 3 seated readings, 5 minutes apart, using the subject's dominant arm).

3. Chronic kidney disease stage 4 or higher defined as an estimated glomerular filtration rate <30 mL/min per 1.73 m2 (abbreviated MDRD equation).

4. Hepatic impairment defined by serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>2 x the upper limit of normal.

5. 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.

6. Severe anemia defined as hemoglobin < 8 g/dL.

7. Congestive heart failure with New York Heart Association Class II, III, or IV symptoms.

8. 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.

9. Any radiocontrast-facilitated study within 30 days prior to Study Day 1.

10. Cerebrovascular accident within the previous 6 months, or have had a transient ischemic attack within the previous year.

11. Pregnant or nursing women; women of childbearing potential must have a negative serum pregnancy test at Screen.

12. Known adverse reaction to losartan and/or ALA.

13. Participation in another clinical trial or have received an investigational agent for any reason within 30 days of Study Day 1.

14. 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.