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NCT01235910 · ClinicalTrials.gov registry record · Phase 4

Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation

A Phase 4 study, sponsored by University of Colorado, Denver.

Terminated
Registry status
Phase 4
Development phase
1
Enrollment target

NCT01235910: Clinical Trial Phase 4 study, sponsored by University of Colorado, Denver.

NCT01235910 is a Phase 4 study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 1 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01235910, a Phase 4 study, was terminated before completion, sponsored by University of Colorado, Denver.

TERMINATED
Registry status
Phase 4
Development phase
1 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and efficacy of the blood pressure medication, aliskiren, in heart transplant patients. In terms of safety, the investigators will evaluate the blood levels of aliskiren and determine if aliskiren alters the blood levels of the anti-rejection medication, cyclosporine, in these patients. In terms of efficacy, the investigators will determine how well aliskiren lowers blood pressure in heart transplant patients.

Primary Outcome

The study was stopped due to difficulty finding patients who met the strict inclusion criteria. Only one patient was started on the study drug. as a result we did not analyze any cyclosporine PK (e.g.(AUCs) for this study.

Interventions

  • DRUG Aliskiren

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2011-05
Est. Completion 2012-12
Phase Phase 4
University of Colorado, Denver

1,283 total trials

Why NCT01235910 stopped before completion

NCT01235910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Aliskiren is the first listed.

NCT01235910 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01235910 about?

NCT01235910 is a clinical study titled "Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation". The purpose of this study is to evaluate the safety and efficacy of the blood pressure medication, aliskiren, in heart transplant patients. In terms of safety, the investigators will evaluate the blood levels of aliskiren and determine if aliskiren alters the blood levels of the anti-rejection medic...

What is the current status of trial NCT01235910?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2011-05. Estimated completion is 2012-12.

What interventions are being tested in trial NCT01235910?

The interventions under investigation include: Aliskiren (DRUG).

Who is sponsoring clinical trial NCT01235910?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01235910's enrollment target sits among peer trials

1 2000th of 2000 the lowest 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 NCT01235910, the US trial registry maintained by the National Library of Medicine. NCT01235910 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.