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NCT00860262 · ClinicalTrials.gov registry record · Phase 3

Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension

A Phase 3 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
858
Enrollment target

NCT00860262 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 858 participants.

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The verdict

NCT00860262, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
858 participants
Enrollment target

Study Summary

The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure \[SBP\] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.

Interventions

  • DRUG amlodipine
  • DRUG telmisartan
  • DRUG telmisartan and amlodipine

Trial Details

FieldValue
Enrollment Target 858 participants
Start Date 2009-03
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT00860262

The ClinicalTrials.gov registry entry for NCT00860262 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 858 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 3 interventions - of which amlodipine is the first listed.

NCT00860262 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00860262 about?

NCT00860262 is a clinical study titled "Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension". The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure \[SBP\] compared to the monotherapies of telmisarta...

What is the current status of trial NCT00860262?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 858 participants. The study started on 2009-03.

What interventions are being tested in trial NCT00860262?

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

Who is sponsoring clinical trial NCT00860262?

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 Editorial

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.