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

NCT01398423 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2012-08-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Active Control

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

DRUG

INV-144

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

Sponsors & Collaborators

  • InVasc Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • William Schaeffer · InVasc Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01398423 on ClinicalTrials.gov