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NCT00654745 · ClinicalTrials.gov registry record · Phase 4

18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics

A Phase 4 study, sponsored by Daiichi Sankyo.

Completed
Registry status
Phase 4
Development phase
207
Enrollment target

NCT00654745: Completed Phase 4 study, sponsored by Daiichi Sankyo.

NCT00654745 is a Phase 4 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 207 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00654745, a Phase 4 study, has completed, sponsored by Daiichi Sankyo.

COMPLETED
Registry status
Phase 4
Development phase
207 participants
Enrollment target

Study Summary

To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.

Primary Outcome

Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.

Interventions

  • DRUG Amlodipine
  • DRUG Hydrochlorothiazide
  • DRUG amlodipine / olmesartan medoxomil combination

Trial Details

FieldValue
Enrollment Target 207 participants
Start Date 2008-05
Est. Completion 2009-06
Phase Phase 4
Daiichi Sankyo

236 total trials

What the finished NCT00654745 record still lists

NCT00654745 is an interventional study that assigns participants to a tested intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower).

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

NCT00654745 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00654745 about?

NCT00654745 is a clinical study titled "18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics". To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.

What is the current status of trial NCT00654745?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 207 participants. The study started on 2008-05. Estimated completion is 2009-06.

What interventions are being tested in trial NCT00654745?

The interventions under investigation include: Amlodipine (DRUG), Hydrochlorothiazide (DRUG), amlodipine / olmesartan medoxomil combination (DRUG).

Who is sponsoring clinical trial NCT00654745?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00654745's enrollment target sits among peer trials

207 401st of 2000 higher than 1,600 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 NCT00654745, the US trial registry maintained by the National Library of Medicine. NCT00654745 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.