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NCT00168857 · ClinicalTrials.gov registry record · Phase 4

A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study)

A Phase 4 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 4
Development phase
860
Enrollment target

NCT00168857: Completed Phase 4 study, sponsored by Boehringer Ingelheim.

NCT00168857 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 860 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (66% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00168857, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 4
Development phase
860 participants
Enrollment target

Study Summary

A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers (ARB) have been shown to slow the decline in kidney function of patients with type 2 diabetes, high blood pressure, and kidney disease. Losartan (COZAAR), is one such drug. The purpose of this research study is to determine if after one year of treatment telmisartan (MICARDIS, GLIOSARTAN, KINZAL, KINZALMONO, PREDXAL, PRITOR, SAMERTAN, TELMISARTAN) 80 mg, another blood pressure lowering drug from the ARB class, is as effective as losartan (COZAAR) 100 mg in reducing the level of urinary protein (indicative of improved kidney function).

Interventions

  • DRUG losartan
  • DRUG telmisartan

Trial Details

FieldValue
Enrollment Target 860 participants
Start Date 2003-07-09
Phase Phase 4
Boehringer Ingelheim

515 total trials

What the finished NCT00168857 record still lists

NCT00168857 is an interventional study that assigns participants to a tested intervention. The registered 860 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (66% higher).

The record links to 0 conditions, and to 2 interventions - of which losartan is the first listed.

NCT00168857 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00168857 about?

NCT00168857 is a clinical study titled "A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study)". A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers (ARB) have been shown to slow the decline in kidney function of patients with type 2 diabetes, high blood pressure, and kidney disease. Losartan (COZAAR), is one such drug. The purpose of this research stud...

What is the current status of trial NCT00168857?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 860 participants. The study started on 2003-07-09.

What interventions are being tested in trial NCT00168857?

The interventions under investigation include: losartan (DRUG), telmisartan (DRUG).

Who is sponsoring clinical trial NCT00168857?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00168857's enrollment target sits among peer trials

860 88th of 2000 higher than 1,913 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00168857, the US trial registry maintained by the National Library of Medicine. NCT00168857 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.