Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low Dose Versus Aggressive Inhibition of the Renin-Angiotensin-Aldosterone (RAS) to Treat Microalbuminuria (END-IT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00907374
Recruitment Status : Completed
First Posted : May 22, 2009
Results First Posted : March 30, 2012
Last Update Posted : March 30, 2012
Sponsor:
Information provided by (Responsible Party):
Mayer Davidson, Charles Drew University of Medicine and Science

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Microalbuminuria
Intervention Drug: benazepril
Enrollment 46
Recruitment Details  
Pre-assignment Details 46 patients were enrolled and entered the run-in but 19 were not randomized
Arm/Group Title Low Dose Inhibition of RAS Agressive Inhibition of the RAS
Hide Arm/Group Description 10 mg benazepril plus other anti-hypertensive agents to treat elevated BP 40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
Period Title: Overall Study
Started 14 13
Completed 12 11
Not Completed 2 2
Reason Not Completed
Noncompliant w/study protocol at <3 mos             2             2
Arm/Group Title Low Dose Inhibition of RAS Agressive Inhibition of the RAS Total
Hide Arm/Group Description 10 mg benazepril plus other anti-hypertensive agents to treat elevated BP 40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day Total of all reporting groups
Overall Number of Baseline Participants 14 13 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
13
 100.0%
27
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 13 participants 27 participants
54.4  (6.7) 51.6  (5.9) 53.0  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
Female
7
  50.0%
6
  46.2%
13
  48.1%
Male
7
  50.0%
7
  53.8%
14
  51.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 13 participants 27 participants
14 13 27
1.Primary Outcome
Title Microalbuminuria Reported as Urinary Albumin:Creatinine Ratio
Hide Description Average of ratio for all participants during the 3-36 months of the study
Time Frame 3 to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Inhibition of RAS Agressive Inhibition of the RAS
Hide Arm/Group Description:
10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: Ratio
256.1  (652.3) 376.2  (404.2)
2.Secondary Outcome
Title Estimated Glomerular Filtration Rate
Hide Description This is an average for all participants during the 3-36 month study period
Time Frame 3 to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Completers
Arm/Group Title Low Dose Inhibition of RAS Agressive Inhibition of the RAS
Hide Arm/Group Description:
10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: ml/min/1.73 meters squared
108.7  (21.6) 100.5  (33.7)
3.Secondary Outcome
Title Carotid Artery Intima Thickness
Hide Description Thickness of intima of right carotid artery; average of all particpants from 6-36 months of study
Time Frame 6 to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Completers
Arm/Group Title Low Dose Inhibition of RAS Agressive Inhibition of the RAS
Hide Arm/Group Description:
10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: mm
0.74  (0.09) 0.72  (0.17)
4.Secondary Outcome
Title Endothelial Dysfunction
Hide Description Post hyperemia increase in blood flow - fold increase from before and after occluding BP; values are mean of all participants in 6-36 months of study period.
Time Frame 6 to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
complerters
Arm/Group Title Low Dose Inhibition of RAS Agressive Inhibition of the RAS
Hide Arm/Group Description:
10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: Fold increase
2.2  (0.5) 2.0  (0.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose Inhibition of RAS Agressive Inhibition of the RAS
Hide Arm/Group Description 10 mg benazepril plus other anti-hypertensive agents to treat elevated BP 40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
All-Cause Mortality
Low Dose Inhibition of RAS Agressive Inhibition of the RAS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Low Dose Inhibition of RAS Agressive Inhibition of the RAS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/13 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Low Dose Inhibition of RAS Agressive Inhibition of the RAS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      2/13 (15.38%)    
Vascular disorders     
Systolic BP <100 mm Hg   0/14 (0.00%)  0 2/13 (15.38%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mayer B. Davidson, MD
Organization: Charles R. Drew University
Phone: 323 357-3439
EMail: mayerdavidson@cdrewu.edu
Layout table for additonal information
Responsible Party: Mayer Davidson, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00907374    
Other Study ID Numbers: IRB# 04-09-772
U54RR014616 ( U.S. NIH Grant/Contract )
First Submitted: May 21, 2009
First Posted: May 22, 2009
Results First Submitted: February 9, 2012
Results First Posted: March 30, 2012
Last Update Posted: March 30, 2012