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Study Complete
Sponsor ID
20140255

Study to Evaluate the Effect of Erenumab on Blood Pressure when Given Concomitantly with Subcutaneous Sumatriptan

Sponsor ID
20140255
Clinicaltrials.gov ID
NCT02741310
EUCTIS ID
N/A
EudraCT ID
2015-004537-28
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Study Details

The primary objective of this study was to assess the effects of subcutaneous sumatriptan alone and the effects of a single dose of erenumab (AMG 334) intravenous (IV) and sumatriptan concomitant therapy on resting blood pressure in healthy adults.

Additional Study Details

Phase
Phase 1
Product
AMG 334
Type
Interventional
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Enrollment
34
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change in individual time-weighted averages of the mean arterial blood pressure in subjects.

Timeframe: 90 days

Secondary Outcome Measures
Not Available

Study Documents

Study Synopsis
Available Language(s): English
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Locations

Location
Status
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Location
Research Site
Leuven, Belgium, 3000
Status
Completed
Study Info
Age
18 - 55 Years
Condition
  • Healthy Subjects
    • Sex
    All
    Trial Dates
    Feb 2016 - Aug 2016
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Healthy male and female subjects ≥ 18 to ≤ 55 years old - Good general health - Laboratory results within range - Other Inclusion Criteria May Apply
    Exclusion Criteria:
    - Female subjects pregnant or breastfeeding - An unstable medical condition - History of cancer - Active liver disease - Positive Hepatitis B or Hepatitis C -Unwilling or unable to limit alcohol consumption -Unable to refrain from strenuous exercise -Other Exclusion Criteria May Apply