CompletedNot Applicable

A Study to Evaluate Whether Losartan Protects the Kidney in Hypertensive Diabetic Participants With Microalbuminuria (MK0954-365 AM1)

136 participantsStarted 2008-09

Plain-language summary

This study will evaluate whether losartan protects the kidney in hypertensive Type II diabetic participants with microalbuminuria.

Who can participate

Age range

20 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Macroalbuminuria After 6 Months of Treatment

Timeframe: Baseline and Month 6

Trial details

NCT IDNCT01390415

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-08

Results submitted2011-08-09

View on ClinicalTrials.gov More Hypertension trials

Who can participate

Age range

20 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.