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NCT00095394 · ClinicalTrials.gov registry record · Phase 3

Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension

A Phase 3 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 3
Development phase
645
Enrollment target

NCT00095394: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.

NCT00095394 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 645 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00095394, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 3
Development phase
645 participants
Enrollment target

Study Summary

The purpose of this clinical research is to learn if severe hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.

Interventions

  • DRUG Irbesartan/HCTZ
  • DRUG Irbesartan monotherapy

Trial Details

FieldValue
Enrollment Target 645 participants
Start Date 2004-09
Est. Completion 2005-05
Phase Phase 3
Bristol-Myers Squibb

1,025 total trials

What the finished NCT00095394 record still lists

NCT00095394 is an interventional study that assigns participants to a tested intervention. The registered 645 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower).

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

NCT00095394 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00095394 about?

NCT00095394 is a clinical study titled "Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension". The purpose of this clinical research is to learn if severe hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate th...

What is the current status of trial NCT00095394?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 645 participants. The study started on 2004-09. Estimated completion is 2005-05.

What interventions are being tested in trial NCT00095394?

The interventions under investigation include: Irbesartan/HCTZ (DRUG), Irbesartan monotherapy (DRUG).

Who is sponsoring clinical trial NCT00095394?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00095394's enrollment target sits among peer trials

645 572nd of 2000 higher than 1,429 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 NCT00095394, the US trial registry maintained by the National Library of Medicine. NCT00095394 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.