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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: Completed Phase 3 study, sponsored by Boehringer Ingelheim.

NCT00860262 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 858 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Overall mean reduction from a common mean baseline in SBP

Interventions

  • DRUG amlodipine
  • DRUG telmisartan
  • DRUG telmisartan and amlodipine

Trial Details

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

515 total trials

What the finished NCT00860262 record still lists

NCT00860262 is an interventional study that assigns participants to a tested intervention. The registered 858 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% higher).

The record links to 0 conditions, and to 3 interventions - of which amlodipine is the first listed.

NCT00860262 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00860262's enrollment target sits among peer trials

858 383rd of 2000 higher than 1,618 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00860262, the US trial registry maintained by the National Library of Medicine. NCT00860262 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.