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Treadmill CV Safety Study

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ClinicalTrials.gov Identifier: NCT02575833
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A phase 2a, multicenter, randomized, double-blind, placebo-controlled study in subjects with stable angina to evaluate the effect of AMG 334 compared to placebo on exercise time during an exercise treadmill test (ETT)

Condition or disease Intervention/treatment Phase
Stable Angina Drug: AMG 334 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of AMG 334 on Exercise Time During a Treadmill Test in Subjects With Stable Angina
Actual Study Start Date : November 23, 2015
Primary Completion Date : January 23, 2017
Study Completion Date : April 13, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: AMG 334 Drug: AMG 334
Single dose of IV AMG 334
Placebo Comparator: Placebo Drug: Placebo
Single dose of IV Placebo


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in total exercise time during an exercise treadmill test in subjects with stable angina. [ Time Frame: Within 6 weeks of screening ]

Secondary Outcome Measures :
  1. Time to onset of exercise-induced angina during an exercise treadmill test [ Time Frame: Within 6 weeks of screening ]
  2. Time to onset of > or = 1 mm of ST-segment depression during an exercise treadmill test [ Time Frame: Within 6 weeks of screening ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: - History of chronic stable angina or at least 3 months prior to screening, with at least 1 angina episode per month

  • Ischemic Heart disease documented by Myocardial Infarction, Coronary angiography or a Revascularization procedure
  • Receiving stable doses of cardiac medication
  • Completes 2 ETTs during screening meeting protocol requirements Exclusion Criteria:
  • Participating in another investigational study
  • Current or prior malignancy within 5 years of randomization
  • Known sensitivity to any components of the investigational product
  • Not able to complete all protocol required study visits
  • Having the following within 3 months prior to or during screening: Unstable angina or acute coronary syndrome, Transient Ischemic attack(TIA) or stroke, Revasculatization procedure, or Instability in ST-segment depression between screening ETTs, as assessed by the core ECG Laboratory
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): NCT02575833


  Show 33 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02575833     History of Changes
Other Study ID Numbers: 20140254
2015-002322-40 ( EudraCT Number )
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by Amgen:
Angina
Stable Angina
Cardiovascular Disease
Exercise-induced Angina

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms