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Safety and Efficacy of Low Doses of V24343 in Obese Subjects

NCT00734201 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2011-07-25

No results posted yet for this study

Summary

Randomised, double-blind, parallel group comparison of four dose levels of V24343 and placebo to study the effect of V24343 on blood pressure and weight in obese subjects.

The primary variables, change in blood pressure (BP) and pulse, will be assessed both by outpatient ambulatory monitoring of vital signs and by regular clinic monitoring.

The efficacy of V24343 will be assessed by measurement of body weight, waist circumference, bioimpedance assessment of body composition and blood glucose.

Assay of plasma concentration of V24343 in blood samples collected at intervals after dosing will be used to assess the pharmacokinetics of V24343.

Other safety assessments comprise routine monitoring of adverse events; concomitant medication; clinical laboratory safety tests, 12-lead electrocardiograms (ECG) and self-completed psychiatric assessments.

Conditions

Interventions

DRUG

V24343

Oral, 1mg, 2 mg, 5 mg or 25 mg, or placebo, once daily for 28 days

Sponsors & Collaborators

  • Vernalis (R&D) Ltd

    lead INDUSTRY

Principal Investigators

  • Steve Warrington · Medical Director

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT00734201 on ClinicalTrials.gov