HypertensionNCT01390415
A Study to Evaluate Whether Losartan Protects the Kidney in Hypertensive Diabetic Participants With Microalbuminuria (MK0954-365 AM1)
An observational study of Hypertension, run by Organon and Co.
Trial summary
This study will evaluate whether losartan protects the kidney in hypertensive Type II diabetic participants with microalbuminuria. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hypertension
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Aug 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with diabetes mellitus and hypertension treated with losartan 50 mg or 100 mg for at least 6 months in a hospital setting in Taiwan
Who may be able to join
- Diabetes mellitus
- Hypertension and has received losartan 50 mg or losartan 100 mg for at least 6 months
- Microalbuminuria (defined as microalbuminuria > 30 mg/g and < 300 mg/g by spot urine test)
- Serum creatinine ≤1.5 mg/dL for men and ≤1.4mg/dL for women
- Urinalysis with white blood cells (WBC) <5 cells per high power field
- Results of hemoglobin A1c (HbA1c), fasting blood glucose, serum creatinine, urine albumin/urine creatinine ratio and urinary analysis tests at baseline and 6 months after initiating the losartan therapy are available
- Medical history and co-morbidities (if available) listed in medical records
- Prescription information of antihypertensive regimen of losartan 50 mg or 100 mg available
Who cannot join
- Treated with angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARB) before initiated treatment with losartan 50 mg or losartan 100 mg
- Enrollment in another clinical trial
About this study
Official title: A Retrospective Survey to Evaluate the Renoprotective Effect of Losartan in Type II Diabetic Patients With Microalbuminuria and Hypertension in Real Life
This study will evaluate whether losartan protects the kidney in hypertensive Type II diabetic participants with microalbuminuria.
- Conditions
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Macroalbuminuria After 6 Months of Treatment
Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) >300 mg/g and ≥30% increase from baseline.
Measured: Baseline and Month 6
Secondary outcomes (2)
Systolic Blood Pressure (SBP)
SBP at baseline and month 6.
Measured: Baseline and Month 6
Diastolic Blood Pressure (DBP)
DBP at baseline and month 6.
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startSep 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390415
- Sponsor's protocol ID
- 0954-365
- Status last verified
- Feb 2022
- First submitted
- 7 Jul 2011
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Survey to Evaluate the Renoprotective Effect of Losartan in Type II Diabetic Patients With Microalbuminuria and Hypertension in Real Life
- ClinicalTrials.gov ID
- NCT01390415
- Acronym / sponsor ID
- 0954-365
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Posted 13 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether losartan protects the kidney in hypertensive Type II diabetic participants with microalbuminuria.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with diabetes mellitus and hypertension treated with losartan 50 mg or 100 mg for at least 6 months in a hospital setting in Taiwan
Key inclusion criteria (8 listed)
- Diabetes mellitus
- Hypertension and has received losartan 50 mg or losartan 100 mg for at least 6 months
- Microalbuminuria (defined as microalbuminuria > 30 mg/g and < 300 mg/g by spot urine test)
- Serum creatinine ≤1.5 mg/dL for men and ≤1.4mg/dL for women
- Urinalysis with white blood cells (WBC) <5 cells per high power field
Key exclusion criteria (2 listed)
- Treated with angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARB) before initiated treatment with losartan 50 mg or losartan 100 mg
- Enrollment in another clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Macroalbuminuria After 6 Months of Treatment
Time frame: Baseline and Month 6
Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) >300 mg/g and ≥30% increase from baseline.
2 secondary outcomes
Systolic Blood Pressure (SBP)
Time frame: Baseline and Month 6
Diastolic Blood Pressure (DBP)
Time frame: Baseline and Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Organon and Co.
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 8 inclusion and 2 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Macroalbuminuria After 6 Months of Treatment (time frame: Baseline and Month 6). 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 9 Feb 2022.