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NCT00239538 · ClinicalTrials.gov registry record · Phase 4

SMOOTH - Blood Pressure Control in Diabetic/Obese Patients

A Phase 4 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 4
Development phase
840
Enrollment target

NCT00239538 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 840 participants.

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The verdict

NCT00239538, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 4
Development phase
840 participants
Enrollment target

Study Summary

The primary objective of this study is to demonstrate that telmisartan 80 mg combined with hydrochlorothiazide 12.5 mg (T80/H12.5) is at least as effective and possibly superior to valsartan 160 mg combined with hydrochlorothiazide 12.5 mg (V160/H12.5) in lowering mean ambulatory systolic blood pressure (SBP) and diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval at the end of a 10-week treatment period in mild-to-moderate hypertensive, overweight or obese patients with type 2 diabetes mellitus

Interventions

  • DRUG telmisartan combined with hydrochlorothiazide (80/12.5 mg)
  • DRUG valsartan combined with hydrochlorothiazide (160/12.5mg)

Trial Details

FieldValue
Enrollment Target 840 participants
Start Date 2003-01
Est. Completion 2004-12
Phase Phase 4

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT00239538

The ClinicalTrials.gov registry entry for NCT00239538 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 840 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which telmisartan combined with hydrochlorothiazide (80/12.5 mg) is the first listed.

NCT00239538 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00239538 about?

NCT00239538 is a clinical study titled "SMOOTH - Blood Pressure Control in Diabetic/Obese Patients". The primary objective of this study is to demonstrate that telmisartan 80 mg combined with hydrochlorothiazide 12.5 mg (T80/H12.5) is at least as effective and possibly superior to valsartan 160 mg combined with hydrochlorothiazide 12.5 mg (V160/H12.5) in lowering mean ambulatory systolic blood pres...

What is the current status of trial NCT00239538?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 840 participants. The study started on 2003-01. Estimated completion is 2004-12.

What interventions are being tested in trial NCT00239538?

The interventions under investigation include: telmisartan combined with hydrochlorothiazide (80/12.5 mg) (DRUG), valsartan combined with hydrochlorothiazide (160/12.5mg) (DRUG).

Who is sponsoring clinical trial NCT00239538?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.