NCT01398423

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P25-P50 for phase_2 hypertension

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

1.1 years

First QC Date

July 19, 2011

Last Update Submit

August 5, 2012

Conditions

HypertensionDiabetes Mellitus, Type 2

Keywords

HypertensionDiabetes mellitisNephropathyAlbuminuria

Outcome Measures

Primary Outcomes (1)

  • Safety

    Safety will be monitored throughout the study by evaluation of adverse events (AEs), physical examinations (PEs), clinical laboratory results, vital signs, and electrocardiograms (ECGs).

    12 weeks

Secondary Outcomes (1)

  • Efficacy

    12 weeks

Study Arms (2)

Active control

ACTIVE COMPARATOR

Losartan potassium (50 mg) plus placebo to match alpha lipoic acid (600 mg)

Drug: Active Control

INV-144

EXPERIMENTAL

INV-144 is a combination drug product consisting of losartan potassium (50mg) and alpha lipoic acid (600 mg)

Drug: INV-144

Interventions

Active ControlDRUG

Losartan potassium (50 mg) plus placebo to match alpha lipoic acid (600 mg)

Active control
INV-144DRUG

INV-144 is a combination drug product consisting of losartan potassium (50mg) and alpha lipoic acid (600 mg)

INV-144

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Unknown Facility

Garden Grove, California, 92844, United States

Location

Unknown Facility

La Mesa, California, 91942, United States

Location

Unknown Facility

Northridge, California, 91324, United States

Location

Unknown Facility

Riverside, California, 92505, United States

Location

Unknown Facility

Tustin, California, 92780, United States

Location

Unknown Facility

Kissimmee, Florida, 34741, United States

Location

Unknown Facility

Miami, Florida, 33015, United States

Location

Unknown Facility

Macon, Georgia, 31217, United States

Location

Unknown Facility

Tucker, Georgia, 30084, United States

Location

Unknown Facility

Reisterstown, Maryland, 21136, United States

Location

Unknown Facility

Brooklyn Center, Minnesota, 55430, United States

Location

Unknown Facility

Cary, North Carolina, 27511, United States

Location

Unknown Facility

Greenville, North Carolina, 27834, United States

Location

Unknown Facility

New Bern, North Carolina, 28562, United States

Location

Unknown Facility

Raleigh, North Carolina, 27610, United States

Location

Unknown Facility

Aiken, South Carolina, 29801, United States

Location

Unknown Facility

San Antonio, Texas, 78215, United States

Location

Unknown Facility

San Antonio, Texas, 78228, United States

Location

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 2Kidney DiseasesAlbuminuria

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesProteinuriaUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William Schaeffer

    InVasc Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 20, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 7, 2012

Record last verified: 2012-08

Locations

US(19)