HypertensionPhase 2NCT01398423
INV-144 Versus Losartan in Hypertension and Type 2 Diabetes Mellitus Patients With Macroalbuminuria
A Phase 2 study testing INV-144 in people with Hypertension and Diabetes Mellitus, Type 2, run by InVasc Therapeutics, Inc. at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Type 2
- What is being tested?
- INV-144
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 19 sitesUnited States
- Study dates
- Jun 2011to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Study site
Aiken, South Carolina, 29801
Study site
Brooklyn Center, Minnesota, 55430
Study site
Cary, North Carolina, 27511
Study site
Garden Grove, California, 92844
Study site
Greenville, North Carolina, 27834
Study site
Kissimmee, Florida, 34741
Study site
La Mesa, California, 91942
Study site
Macon, Georgia, 31217
Study site
Miami, Florida, 33015
Study site
New Bern, North Carolina, 28562
Study site
Norfolk, Virginia, 23507
Study site
Northridge, California, 91324
Study site
Raleigh, North Carolina, 27610
Study site
Reisterstown, Maryland, 21136
Study site
Riverside, California, 92505
Study site
San Antonio, Texas, 78215
Study site
San Antonio, Texas, 78228
Study site
Tucker, Georgia, 30084
Study site
Tustin, California, 92780
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Hypertension, Diabetes Mellitus, Type 2
- Being tested
- Active Control, INV-144
- Keywords
- Hypertension, Diabetes mellitis, Nephropathy, Albuminuria
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Kidney Diseases, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ControlDrug
Losartan potassium (50 mg) plus placebo to match alpha lipoic acid (600 mg)
INV-144Drug
INV-144 is a combination drug product consisting of losartan potassium (50mg) and alpha lipoic acid (600 mg)
| Study group | Role | What they receive |
|---|---|---|
| Active control | Active comparator | Losartan potassium (50 mg) plus placebo to match alpha lipoic acid (600 mg) Receives: Drug: Active Control |
| INV-144 | Experimental | INV-144 is a combination drug product consisting of losartan potassium (50mg) and alpha lipoic acid (600 mg) Receives: Drug: INV-144 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (1)
Efficacy
Efficacy will be evaluated by measurement of UACR, systolic and diastolic blood pressure, and the HOMA-IR ratio.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- InVasc Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Schaeffer, Study director, InVasc Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398423
- Sponsor's protocol ID
- INV144-201
- Status last verified
- Aug 2012
- First submitted
- 19 Jul 2011
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01398423
- Acronym / sponsor ID
- INV144-201
- Conditions
- Hypertension, Diabetes Mellitus, Type 2
- Keywords
- Hypertension, Diabetes mellitis, Nephropathy, Albuminuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- InVasc Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active control | Active comparator | Drug: Active ControlLosartan potassium (50 mg) plus placebo to match alpha lipoic acid (600 mg) |
| INV-144 | Experimental | Drug: INV-144INV-144 is a combination drug product consisting of losartan potassium (50mg) and alpha lipoic acid (600 mg) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active ControlLosartan potassium (50 mg) plus placebo to match alpha lipoic acid (600 mg) | Drug | Active control |
| INV-144INV-144 is a combination drug product consisting of losartan potassium (50mg) and alpha lipoic acid (600 mg) | Drug | INV-144 |
Primary outcome
Safety
Time frame: 12 weeks
Safety will be monitored throughout the study by evaluation of adverse events (AEs), physical examinations (PEs), clinical laboratory results, vital signs, and electrocardiograms (ECGs).
1 secondary outcome
Efficacy
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Schaeffer study director
InVasc Therapeutics, Inc.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INV-144 in people with Hypertension and Diabetes Mellitus, Type 2, run by InVasc Therapeutics, Inc. at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2012.