A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

VIVUS, Inc.

ClinicalTrials.gov Identifier:

NCT00745251

First received: August 31, 2008

Last updated: September 5, 2012

Last verified: September 2012

History of Changes

Results First Received: July 31, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Sleep Apnea
Interventions:	Drug: VI-0521 Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subject recruitment occurred in 1 investigative site in the U.S. between August 2008 to February 2009

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	No text entered.
Top Dose	PHEN/TPM 15mg/92mg

Participant Flow: Overall Study

	Placebo	Top Dose
STARTED	23	22
COMPLETED	21	19
NOT COMPLETED	2	3
Adverse Event	1	2
Withdrawal by Subject	1	1

Baseline Characteristics

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Reporting Groups

	Description
Placebo	No text entered.
Top Dose	PHEN/TPM 15mg/92mg
Total	Total of all reporting groups

Baseline Measures

	Placebo	Top Dose	Total
Number of Participants [units: participants]	23	22	45
Age [units: years] Mean ± Standard Deviation	51.4 ± 5.74	53.4 ± 6.95	52.4 ± 6.37
Gender [units: participants]
Female	8	13	21
Male	15	9	24
Region of Enrollment [units: participants]
United States	23	22	45

Outcome Measures

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1. Primary:

Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term. [ Time Frame: between baseline and Week 28 ]

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2. Secondary:

Percent Change in Weight From Baseline to Week 28 [ Time Frame: baseline to week 28 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: After Sponsor's written notification that publication of results is no longer planned or 12 months after termination of the study at all sites, Institution & PI may publish, upon written approval from Sponsor, results of the Study. Sponsor will be given the opportunity to review any proposed publication at least 60 days prior to submission for publication or disclosure. Upon Sponsor's written request, Institution and PI shall not publish or disclose information related to the Study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Wesley W. Day, PhD
Organization: Vivus, Inc
phone: 650-934-5200
e-mail: day@vivus.com

No publications provided

Responsible Party:	VIVUS, Inc.
ClinicalTrials.gov Identifier:	NCT00745251 History of Changes
Other Study ID Numbers:	OB-204
Study First Received:	August 31, 2008
Results First Received:	July 31, 2012
Last Updated:	September 5, 2012
Health Authority:	United States: Food and Drug Administration

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