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COMPLETED Phase 3

A Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis

NCT00646035 · View on ClinicalTrials.gov ↗

Study Summary

To determine the safety and efficacy of paricalcitol capsules as compared to placebo for treatment of secondary hyperparathyroidism by decreasing serum intact parathyroid hormone levels in end stage renal disease subjects on peritoneal dialysis.

Conditions Studied

Interventions

  • DRUG paricalcitol capsules

Study Locations (20)

Ohio

  • — Cincinnati
  • — Cincinnati
  • — Cleveland

Florida

  • — Fort Myers
  • — Tampa

Illinois

  • — Evanston
  • — Maywood

Tennessee

  • — Memphis
  • — Nashville

California

  • — Los Angeles

Colorado

  • — Denver

District of Columbia

  • — Washington D.C.

Georgia

  • — Savannah

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2002-01
Phase Phase 3

Sponsor

Abbott

43 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00646035

The ClinicalTrials.gov registry entry for NCT00646035 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott, which has 43 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with End Stage Renal Disease appearing as the primary indexed condition, and to 1 intervention — of which paricalcitol capsules is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00646035 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Ohio, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00646035 about?

NCT00646035 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis". To determine the safety and efficacy of paricalcitol capsules as compared to placebo for treatment of secondary hyperparathyroidism by decreasing serum intact parathyroid hormone levels in end stage renal disease subjects on peritoneal dialysis.

What is the current status of trial NCT00646035?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2002-01.

What conditions does trial NCT00646035 study?

This clinical trial studies the following conditions: End Stage Renal Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00646035?

The interventions under investigation include: paricalcitol capsules (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00646035?

This trial is sponsored by Abbott, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00646035 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial