Trial Outcomes & Findings for A Study to Evaluate Whether Losartan Protects the Kidney in Hypertensive Diabetic Participants With Microalbuminuria (MK0954-365 AM1) (NCT NCT01390415)
NCT ID: NCT01390415
Last Updated: 2022-02-09
Results Overview
Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) \>300 mg/g and ≥30% increase from baseline.
Recruitment status
COMPLETED
Target enrollment
136 participants
Primary outcome timeframe
Baseline and Month 6
Results posted on
2022-02-09
Participant Flow
All the medical charts of the targeted study patients were reviewed. The study index period (when patients had to have received treatment for 6 months) was from June 1st 2007 to December 31st 2008. Data were collected retrospectively.
211 patients were enrolled in this study. Among these patients, 136 patients were eligible after excluding 75 patients.
Participant milestones
| Measure |
Losartan 50 mg
Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
|
Losartan 100 mg
Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
37
|
|
Overall Study
COMPLETED
|
99
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Whether Losartan Protects the Kidney in Hypertensive Diabetic Participants With Microalbuminuria (MK0954-365 AM1)
Baseline characteristics by cohort
| Measure |
Losartan 50 mg
n=99 Participants
Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
|
Losartan 100 mg
n=37 Participants
Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
59.0 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 6Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) \>300 mg/g and ≥30% increase from baseline.
Outcome measures
| Measure |
Losartan 50 mg
n=99 Participants
Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
|
Losartan 100 mg
n=37 Participants
Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
|
|---|---|---|
|
Number of Participants With Macroalbuminuria After 6 Months of Treatment
|
7 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Baseline and Month 6SBP at baseline and month 6.
Outcome measures
| Measure |
Losartan 50 mg
n=99 Participants
Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
|
Losartan 100 mg
n=37 Participants
Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
|
|---|---|---|
|
Systolic Blood Pressure (SBP)
Baseline (n=85; n=36)
|
149.5 mmHg
Standard Deviation 16.0
|
145.5 mmHg
Standard Deviation 11.1
|
|
Systolic Blood Pressure (SBP)
Month 6 (n=72; n=22)
|
136.9 mmHg
Standard Deviation 14.0
|
138.4 mmHg
Standard Deviation 11.3
|
|
Systolic Blood Pressure (SBP)
Change from Baseline at Month 6 (n=72; n=22)
|
-14.0 mmHg
Standard Deviation 1.6
|
-7.0 mmHg
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline and Month 6DBP at baseline and month 6.
Outcome measures
| Measure |
Losartan 50 mg
n=99 Participants
Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
|
Losartan 100 mg
n=37 Participants
Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
|
|---|---|---|
|
Diastolic Blood Pressure (DBP)
Baseline (n=85; n=36)
|
85.6 mmHg
Standard Deviation 12.4
|
84.0 mmHg
Standard Deviation 8.7
|
|
Diastolic Blood Pressure (DBP)
Month 6 (n=72; n=22)
|
78.2 mmHg
Standard Deviation 8.8
|
80.1 mmHg
Standard Deviation 8.2
|
|
Diastolic Blood Pressure (DBP)
Change from Baseline at Month 6 (n=72; n=22)
|
-9.3 mmHg
Standard Deviation 1.2
|
-4.4 mmHg
Standard Deviation 2.2
|
Adverse Events
Losartan 50 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Losartan 100 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER