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Clinical Trials/NCT01472848
NCT01472848
Withdrawn
Phase 1

A Randomized, Double-Blind, Outpatient, Placebo-Controlled, Dose Titration Study Of Gastrointestinal Tolerability Of Pf 05212389 (Oap-189) In Obese Subjects

Pfizer0 sitesApril 2011
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ConditionsObesity
InterventionsPF 05212389 or placebo
DrugsPF 05212389 or placebo

Overview

Phase
Phase 1
Intervention
PF 05212389 or placebo
Conditions
Obesity
Sponsor
Pfizer
Primary Endpoint
- Incidence, severity and duration of nausea and vomiting collected as adverse events.
Status
Withdrawn
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

This study examines whether a gradual increase of dose improves the gastrointestinal tolerability (nausea and vomiting) of PF05212389

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
August 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pfizer

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • •Diabetes mellitus (type 1 or type 2) Heart failure Eating disorders Psychiatric disorders History of suicide attempt History of pancreatitis

Arms & Interventions

Cohort 1

Intervention: PF 05212389 or placebo

Cohort 2

Intervention: PF 05212389 or placebo

Cohort 3

Intervention: PF 05212389 or placebo

Cohort 4

Intervention: PF 05212389 or placebo

Cohort 5

Intervention: PF 05212389 or placebo

Cohort 6

Intervention: PF 05212389 or placebo

Outcomes

Primary Outcomes

- Incidence, severity and duration of nausea and vomiting collected as adverse events.

Time Frame: Day 1 to day 28

Secondary Outcomes

  • - Change in body weight from baseline(Day 1 to day 28)
  • - Changes in heart rate, systolic and diastolic blood pressure, and ECG parameters from baseline(Day 1 to day 28)
  • - Multiple dose PK parameters of PF 05212389(Day 1 to day 28)
  • - Treatment modification defined as a decrease in any dose of, or discontinuation from, study medication for any reason(Day 1 to day 28)

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