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Caduet and TLC Intervention in Metabolic Syndrome

NCT03504735 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2018-06-13

No results posted yet for this study

Summary

To evaluate the effectiveness of Caduet in addition to therapeutic life-style change (TLC) intervention in resolving metabolic syndrome fifty three individuals were randomized to TLC intervention study with or without Caduet therapy for 12 months. The participants underwent monthly visits with investigators to obtain vital signs, and to undergo TLC counseling. Metabolic parameters were measured before and after intervention.

Conditions

  • Metabolic Syndrome

Interventions

BEHAVIORAL

Therapeutic Lifestyle Change

Monthly consult with a dietitian and fitness instructor.

DRUG

Caduet Pill

Take once daily.

DRUG

Placebo

Take once daily.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    collaborator OTHER

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Nicola Abate, MD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-01
Primary Completion
2009-01-01
Completion
2016-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03504735 on ClinicalTrials.gov