We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00563368
First Posted: November 26, 2007
Last Update Posted: March 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
VIVUS, Inc.
  Purpose
The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.

Condition Intervention Phase
Obesity Drug: VI-0521 Drug: topiramate Drug: phentermine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Parallel-Design Study Comparing Multiple Doses of VI-0521 to Placebo and Their Single-Agent Phentermine and Topiramate Constituents for the Treatment of Obesity in Adults

Resource links provided by NLM:


Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • Percent Weight Loss From Baseline to Week 28 [ Time Frame: baseline to 28 weeks ]
    Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF)

  • Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF [ Time Frame: baseline to 28 weeks ]

Enrollment: 756
Study Start Date: December 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VI-0521 Top
VI-0521; high dose phentermine/topiramate
Drug: VI-0521
phentermine 15 mg and topiramate 92 mg, po once daily
Experimental: VI-0521 Mid
VI-0521; mid dose phentermine/topiramate
Drug: VI-0521
phentermine 7.5 mg and topiramate 46 mg, po once daily
Active Comparator: TPM 46
mid dose topiramate
Drug: topiramate
topiramate 46 mg, po once daily
Active Comparator: TPM 92
high dose topiramate
Drug: topiramate
topiramate 92 mg, po once daily
Active Comparator: PHEN 7.5
mid dose phentermine
Drug: phentermine
phentermine 7.5 mg, po once daily
Active Comparator: PHEN 15
high dose phentermine
Drug: phentermine
phentermine 15 mg, po once daily
Placebo Comparator: Placebo Drug: VI-0521
placebo, po once daily

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 70 years of age or less with body mass index (BMI) between 30 and 45 kg/m2
  • Informed Consent
  • Females of child-bearing potential must be using adequate contraception

Exclusion Criteria:

  • Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months
  • Clinically significant renal, hepatic or psychiatric disease
  • Unstable thyroid disease or replacement therapy
  • Nephrolithiasis
  • Obesity of known genetic or endocrine origin
  • Participation in a formal weight loss program or lifestyle intervention
  • Glaucoma or elevated intraocular pressure
  • Pregnancy or breastfeeding
  • Drug or Alcohol abuse
  • Smoking cessation within previous 3 months or plans to quit smoking during study
  • Eating disorders within past year
  • Cholelithiasis within past 6 months
  • Type 2 diabetes
  • Previous bariatric surgery
  • Bipolar disorder or psychosis
  • Steroid hormone therapy not stable for 3 months
  • Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00563368


Locations
United States, North Carolina
Research Site
Durham, North Carolina, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
VIVUS, Inc.
Medpace, Inc.
Investigators
Study Director: Craig Peterson VIVUS, Inc.
Study Chair: Kishore Gadde, MD Duke University
  More Information

Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00563368     History of Changes
Other Study ID Numbers: OB-301
First Submitted: November 21, 2007
First Posted: November 26, 2007
Results First Submitted: July 31, 2012
Results First Posted: September 3, 2012
Last Update Posted: March 30, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Topiramate
Phentermine
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Central Nervous System Stimulants
Appetite Depressants
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action