Trial Outcomes & Findings for Low Dose Versus Aggressive Inhibition of the Renin-Angiotensin-Aldosterone (RAS) to Treat Microalbuminuria (NCT NCT00907374)

NCT ID: NCT00907374

Last Updated: 2012-03-30

Results Overview

Average of ratio for all participants during the 3-36 months of the study

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 46 participants
• Primary outcome timeframe: 3 to 36 months
• Results posted on: 2012-03-30

Participant Flow

46 patients were enrolled and entered the run-in but 19 were not randomized

Participant milestones

Measure	Low Dose Inhibition of RAS 10 mg benazepril plus other anti-hypertensive agents to treat elevated BP	Agressive Inhibition of the RAS 40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
Overall Study STARTED	14	13
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Low Dose Inhibition of RAS 10 mg benazepril plus other anti-hypertensive agents to treat elevated BP	Agressive Inhibition of the RAS 40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
Overall Study Noncompliant w/study protocol at <3 mos	2	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Low Dose Inhibition of RAS n=14 Participants 10 mg benazepril plus other anti-hypertensive agents to treat elevated BP	Agressive Inhibition of the RAS n=13 Participants 40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	54.4 years STANDARD_DEVIATION 6.7 • n=5 Participants	51.6 years STANDARD_DEVIATION 5.9 • n=7 Participants	53.0 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	13 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 to 36 months

Average of ratio for all participants during the 3-36 months of the study

Outcome measures

Measure	Low Dose Inhibition of RAS n=12 Participants 10 mg benazepril plus other anti-hypertensive agents to treat elevated BP	Agressive Inhibition of the RAS n=11 Participants 40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
Microalbuminuria Reported as Urinary Albumin:Creatinine Ratio	256.1 Ratio Standard Deviation 652.3	376.2 Ratio Standard Deviation 404.2

SECONDARY outcome

Timeframe: 3 to 36 months

Population: Completers

This is an average for all participants during the 3-36 month study period

Outcome measures

Measure	Low Dose Inhibition of RAS n=12 Participants 10 mg benazepril plus other anti-hypertensive agents to treat elevated BP	Agressive Inhibition of the RAS n=11 Participants 40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
Estimated Glomerular Filtration Rate	108.7 ml/min/1.73 meters squared Standard Deviation 21.6	100.5 ml/min/1.73 meters squared Standard Deviation 33.7

SECONDARY outcome

Timeframe: 6 to 36 months

Population: Completers

Thickness of intima of right carotid artery; average of all particpants from 6-36 months of study

Outcome measures

Measure	Low Dose Inhibition of RAS n=12 Participants 10 mg benazepril plus other anti-hypertensive agents to treat elevated BP	Agressive Inhibition of the RAS n=11 Participants 40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
Carotid Artery Intima Thickness	0.74 mm Standard Deviation 0.09	0.72 mm Standard Deviation 0.17

SECONDARY outcome

Timeframe: 6 to 36 months

Population: complerters

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.

Outcome measures

Measure	Low Dose Inhibition of RAS n=12 Participants 10 mg benazepril plus other anti-hypertensive agents to treat elevated BP	Agressive Inhibition of the RAS n=11 Participants 40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
Endothelial Dysfunction	2.2 Fold increase Standard Deviation 0.5	2.0 Fold increase Standard Deviation 0.7

Adverse Events

Low Dose Inhibition of RAS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Agressive Inhibition of the RAS

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Low Dose Inhibition of RAS n=14 participants at risk 10 mg benazepril plus other anti-hypertensive agents to treat elevated BP	Agressive Inhibition of the RAS n=13 participants at risk 40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
Vascular disorders Systolic BP <100 mm Hg	0.00% 0/14	15.4% 2/13 • Number of events 2

Additional Information

Mayer B. Davidson, MD

Charles R. Drew University

Phone: 323 357-3439

Email: mayerdavidson@cdrewu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place