Trial Outcomes & Findings for Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults (NCT NCT00554216)

NCT ID: NCT00554216

Last Updated: 2012-09-10

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1267 participants

Primary outcome timeframe

baseline to 56 weeks

Results posted on

2012-09-10

Participant Flow

Subject recruitment occurred at investigative sites in the US between November 2007 through May 2008

Participant milestones

Participant milestones
Measure	Placebo	VI-0521 Low PHEN/TPM 3.75 mg/23 mg	VI-0521 Top PHEN/TPM 15 mg/92 mg
Overall Study STARTED	514	241	512
Overall Study COMPLETED	272	147	340
Overall Study NOT COMPLETED	242	94	172

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo	VI-0521 Low PHEN/TPM 3.75 mg/23 mg	VI-0521 Top PHEN/TPM 15 mg/92 mg
Overall Study Lost to Follow-up	92	31	63
Overall Study Adverse Event	16	16	36
Overall Study Withdrawal by Subject	92	31	43
Overall Study Non compliance	10	4	5
Overall Study Pregnancy	2	1	14
Overall Study Restricted med	3	1	1
Overall Study Other	12	7	10
Overall Study Lack of Efficacy	15	3	0

Baseline Characteristics

Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=514 Participants	VI-0521 Low n=241 Participants PHEN/TPM 3.75/23	VI-0521 Top n=512 Participants PHEN/TPM 15/92	Total n=1267 Participants Total of all reporting groups
Age Continuous	43.0 years STANDARD_DEVIATION 11.76 • n=5 Participants	43.0 years STANDARD_DEVIATION 10.96 • n=7 Participants	42.0 years STANDARD_DEVIATION 12.21 • n=5 Participants	42.6 years STANDARD_DEVIATION 11.80 • n=4 Participants
Sex: Female, Male Female	425 Participants n=5 Participants	201 Participants n=7 Participants	424 Participants n=5 Participants	1050 Participants n=4 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	40 Participants n=7 Participants	88 Participants n=5 Participants	217 Participants n=4 Participants
Region of Enrollment United States	514 participants n=5 Participants	241 participants n=7 Participants	512 participants n=5 Participants	1267 participants n=4 Participants

PRIMARY outcome

Timeframe: baseline to 56 weeks

Population: intent-to-treat last-observation-carried-forward (ITT-LOCF)

Outcome measures

Outcome measures
Measure	Placebo n=498 Participants	VI-0521 Low n=234 Participants PHEN/TPM 3.75 mg/23 mg	VI-0521 Top n=498 Participants PHEN/TPM 15 mg/92 mg
Percent Weight Loss From Baseline to Week 56	1.55 percent weight loss Standard Error 0.395	5.10 percent weight loss Standard Error 0.538	10.92 percent weight loss Standard Error 0.392

PRIMARY outcome

Timeframe: baseline to 56 weeks

Population: intent-to-treat last-observation-carried-forward (ITT-LOCF)

Outcome measures

Outcome measures
Measure	Placebo n=498 Participants	VI-0521 Low n=234 Participants PHEN/TPM 3.75 mg/23 mg	VI-0521 Top n=498 Participants PHEN/TPM 15 mg/92 mg
Percentage of Subjects With at Least 5% Weight Loss at Week 56	17.3 percentage of participants	44.9 percentage of participants	66.7 percentage of participants

Adverse Events

Placebo

Serious events: 14 serious events

Other events: 374 other events

Deaths: 0 deaths

VI-0521 Low

Serious events: 6 serious events

Other events: 192 other events

Deaths: 0 deaths

VI-0521 Top

Serious events: 13 serious events

Other events: 432 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Wesley W. Day PhD

Vivus, Inc.

Phone: 650-934-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=513 participants at risk	VI-0521 Low n=240 participants at risk PHEN/TPM 3.75/23	VI-0521 Top n=511 participants at risk PHEN/TPM 15/92
Infections and infestations upper respiratory tract infection	10.9% 56/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	15.8% 38/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	12.3% 63/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Infections and infestations nasopharyngitis	7.2% 37/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	12.5% 30/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	9.0% 46/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Infections and infestations sinusitis	5.5% 28/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	7.5% 18/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	7.2% 37/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Infections and infestations influenza	4.7% 24/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	7.5% 18/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	5.1% 26/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Infections and infestations bronchitis	4.3% 22/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	6.7% 16/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	5.5% 28/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Gastrointestinal disorders constipation	6.8% 35/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	7.9% 19/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	14.1% 72/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Gastrointestinal disorders dry mouth	3.7% 19/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	6.7% 16/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	17.0% 87/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Gastrointestinal disorders nausea	4.7% 24/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	5.8% 14/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	7.2% 37/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Gastrointestinal disorders diarrhea	4.5% 23/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	5.0% 12/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	4.7% 24/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Nervous system disorders headache	10.1% 52/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	10.4% 25/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	11.9% 61/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Nervous system disorders paresthesia	1.9% 10/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	4.2% 10/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	18.8% 96/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Nervous system disorders dizziness	4.1% 21/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	2.9% 7/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	5.7% 29/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Nervous system disorders dysgeusia	0.97% 5/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	1.2% 3/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	8.4% 43/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Musculoskeletal and connective tissue disorders back pain	5.1% 26/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	5.4% 13/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	5.5% 28/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Psychiatric disorders insomnia	4.9% 25/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	5.0% 12/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	7.8% 40/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
General disorders fatigue	3.3% 17/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	5.0% 12/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	4.5% 23/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders cough	3.5% 18/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	3.3% 8/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	5.1% 26/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Eye disorders vision blurred	3.1% 16/513 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	6.2% 15/240 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	4.5% 23/511 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.