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NCT00818779 · ClinicalTrials.gov registry record · Phase 4

Direct Renin Inhibition Effects on Atherosclerotic Biomarkers

A Phase 4 study, sponsored by Texas Tech University Health Sciences Center.

Completed
Registry status
Phase 4
Development phase
38
Enrollment target

NCT00818779: Completed Phase 4 study, sponsored by Texas Tech University Health Sciences Center.

NCT00818779 is a Phase 4 study that has completed, run by Texas Tech University Health Sciences Center. The registered enrollment target is 38 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00818779, a Phase 4 study, has completed, sponsored by Texas Tech University Health Sciences Center.

COMPLETED
Registry status
Phase 4
Development phase
38 participants
Enrollment target

Study Summary

The investigators aim to assess if a new blood pressure medication, aliskiren, reduces various biomarkers of heart disease found in the blood in patients with a history of both heart disease and type 2 diabetes. The primary hypothesis is that aliskiren will reduce these biomarkers compared to a calcium channel blocker.

Primary Outcome

Plasminogen Activator Inhibitor 1 is a biomarker found in serum that indirectly assesses blood clotting activity. Lower PAI-1 levels are thought to be better than higher levels. The primary outcome is mean change from baseline and can include negative numbers as a result.

Interventions

  • DRUG Amlodipine
  • DRUG Aliskiren

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2008-01
Est. Completion 2011-08
Phase Phase 4

What the finished NCT00818779 record still lists

NCT00818779 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).

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

NCT00818779 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00818779 about?

NCT00818779 is a clinical study titled "Direct Renin Inhibition Effects on Atherosclerotic Biomarkers". The investigators aim to assess if a new blood pressure medication, aliskiren, reduces various biomarkers of heart disease found in the blood in patients with a history of both heart disease and type 2 diabetes. The primary hypothesis is that aliskiren will reduce these biomarkers compared to a calc...

What is the current status of trial NCT00818779?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2008-01. Estimated completion is 2011-08.

What interventions are being tested in trial NCT00818779?

The interventions under investigation include: Amlodipine (DRUG), Aliskiren (DRUG).

Who is sponsoring clinical trial NCT00818779?

This trial is sponsored by Texas Tech University Health Sciences Center, which has 76 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00818779's enrollment target sits among peer trials

38 1476th of 2000 higher than 519 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 NCT00818779, the US trial registry maintained by the National Library of Medicine. NCT00818779 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.