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NCT01004705 · ClinicalTrials.gov registry record · Phase 2

A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol

A Phase 2 study, sponsored by Ferrer Internacional S.A..

Terminated
Registry status
Phase 2
Development phase
36
Enrollment target

NCT01004705: Clinical Trial Phase 2 study, sponsored by Ferrer Internacional S.A..

NCT01004705 is a Phase 2 study that was terminated before completion, run by Ferrer Internacional S.A.. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01004705, a Phase 2 study, was terminated before completion, sponsored by Ferrer Internacional S.A..

TERMINATED
Registry status
Phase 2
Development phase
36 participants
Enrollment target

Study Summary

This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of simvastatin given alone. Approximately 76 subjects will be screened, 60 randomized in order about 52 subjects to finish the study.

Primary Outcome

Change from baseline in LDL cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.

Interventions

  • DRUG Simvastatin
  • DRUG Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril),

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2009-09
Est. Completion 2011-03
Phase Phase 2
Ferrer Internacional S.A.

3 total trials

Why NCT01004705 stopped before completion

NCT01004705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).

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

NCT01004705 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01004705 about?

NCT01004705 is a clinical study titled "A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol". This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of simvastatin given alone. Approximately 76 subjects will be screened, 60...

What is the current status of trial NCT01004705?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2009-09. Estimated completion is 2011-03.

What interventions are being tested in trial NCT01004705?

The interventions under investigation include: Simvastatin (DRUG), Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril), (DRUG).

Who is sponsoring clinical trial NCT01004705?

This trial is sponsored by Ferrer Internacional S.A., which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01004705's enrollment target sits among peer trials

36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01004705, the US trial registry maintained by the National Library of Medicine. NCT01004705 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.