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A Study of the Safety and Effectiveness of JNJ-16269110 (R256918) in Overweight and Obese Patients

NCT00622765 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2014-05-13

No results posted yet for this study

Summary

This study investigates the effectiveness and safety of 12 weeks of treatment with JNJ-16269110 (R256918), in overweight and obese patients. The primary measure of effectiveness is the change in body weight at a clinically relevant dosage level during treatment. Additional measures include body mass index (BMI), DEXA (dual X-ray absorptiometry which is a specialized x-ray test that measures body composition), fasting glucose, lipid levels, and blood pressure. Safety assessments performed during the trial include laboratory tests, vital sign measurements, and adverse event reporting.

Conditions

Interventions

DRUG

placebo

Placebo capsule twice daily

DRUG

R256918

5 mg capsule twice daily

DRUG

R256918

10 mg capsule twice daily

DRUG

R256918

15 mg capsule twice daily

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Belgium
  • Denmark
  • Finland
  • Germany
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00622765 on ClinicalTrials.gov