Olmesartan Medoxomil in Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4449 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Olmesartan Medoxomil and Diabetic Nephropathy

NCT00362960

Type 2 Diabetes Mellitus Diabetic Nephropathy Proteinuria +1 more

COMPLETED PHASE3

A Phase 2b Diabetic Kidney Disease Study

NCT04170543

Diabetic Kidney Disease

COMPLETED PHASE2

ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial

NCT00141453

Diabetic Nephropathy Type 2 Diabetes Mellitus Proteinuria

COMPLETED PHASE3

A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes

NCT02413398

Type 2 Diabetes Mellitus

COMPLETED PHASE3

A Study to Look at the Effect MEDI0382 Has on Blood Sugar in People With Type 2 Diabetes and Kidney Problems and Also to Check That MEDI0382 is Well Tolerated

NCT03550378

Type II Diabetes Mellitus Renal Insufficiency

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2 Cardiovascular Disease Kidney Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

olmesartan medoxomil

Group Type EXPERIMENTAL

Olmesartan medoxomil

Intervention Type DRUG

tablets

2

placebo

Group Type PLACEBO_COMPARATOR

Placebo Tablets

Intervention Type DRUG

Tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Olmesartan medoxomil

tablets

Intervention Type DRUG

Placebo Tablets

Tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diabetes mellitus type 2, defined as fasting blood glucose of greater than or equal to 126 mg/dL;
* Presence of at least one of the following cardiovascular risk factors:

1. total cholesterol greater than 200 mg/dL or statin treatment,
2. High density lipoprotein (HDL) less than 40 mg/dL,
3. triglycerides greater than 150 mg/dL and less than 400 mg/dL,
4. blood pressure greater than or equal to 130/80 mmHg,
5. Body mass index (BMI) greater than 28 kg/m2,
6. waist circumference greater than 102 cm for men and greater than 88 cm for women,
7. smoking of more than 5 cigarettes a day;
* Normoalbuminuria at screening

Exclusion Criteria

* Severe uncontrolled hyperlipidemia;
* Documented renal and/or renal-vascular disease;
* Myocardial infarction, stroke or myocardial revascularization within the last 6 months;
* History of alcohol and/or drug abuse;
* Allergic reaction, lack of response or contraindication to angiotensin receptor blockers (ARBs);
* Current treatment with an ARB or angiotensin converting enzyme (ACE) inhibitor

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No