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COMPLETED Phase 4

Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina

NCT01425359 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate the effect of ranolazine compared to placebo on the average weekly angina frequency in subjects with chronic stable angina and coronary artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM), and whether ranolazine can reduce the frequency of angina (chest pain) attacks, compared to a placebo. Subjects will be asked to record their daily angina episodes in a diary at the end of each study day. Ranolazine is approved for the treatment of chronic angina, and is not approved for the treatment of T2DM.

Interventions

  • DRUG Ranolazine
  • DRUG Ranolazine placebo

Study Locations (20)

California

  • Merced Heart Associates — Merced
  • Spectrum Clinical Research Institute, Inc — Moreno Valley
  • Sacramento Heart and Vascular Research Center — Sacramento

Florida

  • South Florida Research Solutions, LLC — Hollywood
  • Baptist Heart Specialist — Jacksonville
  • Clinical Research of Central Florida — Winter Haven

Georgia

  • Masters of Clinical Research, Inc. — Augusta
  • Columbus Cardiology Associates — Columbus

Kentucky

  • Central Cardiology Associates — Elizabethtown
  • Research Integrity, LLC — Owensboro

Louisiana

  • Alexandria Cardiology Clinic — Alexandria
  • Clinical Trials Management, LLC — Mandeville

Tennessee

  • Kore CV Research — Jackson
  • Wellmont Cardiovascular Associates Heart Institute — Johnson City

Texas

  • Med-Tech Research — Houston
  • Humble Cardiology Associates — Humble

Arkansas

  • Cardiology and Medicine Clinic — Little Rock

Trial Details

FieldValue
Enrollment Target 949 participants
Start Date 2011-09
Est. Completion 2012-10
Phase Phase 4

Sponsor

Gilead Sciences

190 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01425359

The ClinicalTrials.gov registry entry for NCT01425359 describes a study currently listed as completed. It is categorized as Phase 4, 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 949 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions — of which Ranolazine 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: NCT01425359 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Georgia. 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 NCT01425359 about?

NCT01425359 is a clinical study titled "Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina". This study will evaluate the effect of ranolazine compared to placebo on the average weekly angina frequency in subjects with chronic stable angina and coronary artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM), and whether ranolazine can reduce the frequency of angina (ches...

What is the current status of trial NCT01425359?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 949 participants. The study started on 2011-09. Estimated completion is 2012-10.

What conditions does trial NCT01425359 study?

This clinical trial studies the following conditions: Coronary Artery Disease, Type 2 Diabetes Mellitus, Angina Pectoris. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01425359?

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

Who is sponsoring clinical trial NCT01425359?

This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01425359 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Georgia, Kentucky. 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