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Trial record 46 of 231 for:    CALCITONIN SALMON

A Study to Assess the Safety, Tolerability, and Effects of MK-0974 (Telcagepant) on Exercise Tolerance in Patients With Stable Angina (MK-0974-014)

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ClinicalTrials.gov Identifier: NCT01294709
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : September 10, 2014
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Angina Pectoris
Coronary Heart Disease
Calcitonin Gene-related Peptide Receptor
Interventions Drug: telcagepant
Drug: Placebo to telcagepant
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Telcagepant Then Placebo Placebo Then Telcagepant
Hide Arm/Group Description Participants receive single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 1 and single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours. Participants receive single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 1 and a single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours.
Period Title: Period 1
Started 31 33
Completed 30 32
Not Completed 1 1
Period Title: Washout Period
Started 30 32
Completed 29 31
Not Completed 1 1
Period Title: Period 2
Started 29 31
Completed 28 31
Not Completed 1 0
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description All enrolled participants who recieved at least one dose of either telcagepant or placebo.
Overall Number of Baseline Participants 64
Hide Baseline Analysis Population Description
All enrolled participants who received at least one dose of study drug.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 64 participants
63.5
(38 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Female
9
  14.1%
Male
55
  85.9%
1.Primary Outcome
Title Number of Participants With Clinical Adverse Events (AEs)
Hide Description An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.
Time Frame Up to 10 days post dose in Period 1 and up to 14 days post dose in Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population which consisted of all enrolled participants who actually received assigned study drug in a particular period . Adverse events are reported by dose taken in a given treatment period and not by randomly assigned treatment sequence.
Arm/Group Title Telcagepant (600 mg) Telcagepant (900 mg) Placebo
Hide Arm/Group Description:
Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover
Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover
Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
Overall Number of Participants Analyzed 46 16 62
Measure Type: Number
Unit of Measure: Participants
7 1 5
2.Primary Outcome
Title Number of Participants With Laboratory Adverse Events
Hide Description An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.
Time Frame Up to 10 days post dose in Period 1 and up to 14 days post dose in Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population which consisted of all enrolled participants who actually received assigned study drug in a particular period . Adverse events are reported by dose taken in a given treatment period and not by randomly assigned treatment sequence.
Arm/Group Title Telcagepant (600 mg) Telcagepant (900 mg) Placebo
Hide Arm/Group Description:
Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover
Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover
Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
Overall Number of Participants Analyzed 46 16 62
Measure Type: Number
Unit of Measure: Participants
0 0 0
3.Primary Outcome
Title Total Exercise Duration on the Treadmill Test
Hide Description Bruce (and Modified Bruce) Protocol was used to assess the exercise duration on a treadmill. This protocol consists of a standardized gradual incremental increase in external workload every 3 minutes while the participant’s electrocardiogram (ECG), symptoms, and arm blood pressure were continuously monitored. Regardless of whether the participant believed he or she could continue, the test was discontinued upon evidence of chest discomfort, severe shortness of breath, dizziness, fatigue, ST-segment depression of greater than 2 mm, a fall in systolic blood pressure exceeding 10 mmHg, or the development of a ventricular tachyarrhythmia
Time Frame 2.5 to approximately 2.75 hours post dose of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with evaluable treadmill exercise duration data available. Data from the 600 and 900 mg telcagepant treatments were grouped for comparsion to placebo.
Arm/Group Title Telcagepant Placebo
Hide Arm/Group Description:
Participants who received a single oral dose of 600 mg (or bioequivalent 560 mg tablets) or 900 mg telcagepant in Period 1 or 2 of crossover
Participants who received single oral dose of placebo in Period 1 or 2 of crossover
Overall Number of Participants Analyzed 60 58
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Seconds
405.38
(375.91 to 434.85)
412.28
(382.72 to 441.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant, Placebo
Comments Telcagepant minus Placebo Treatment Difference
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method mixed effects model
Comments mixed effects model with MK-0974 pooled over doses
Method of Estimation Estimation Parameter Difference in Least Squares Means
Estimated Value -6.90
Confidence Interval (2-Sided) 90%
-17.66 to 3.86
Estimation Comments [Not Specified]
4.Secondary Outcome
Title ST Segment Depression at Peak Exercise
Hide Description Bruce (and Modified Bruce) Protocol was used to assess the exercise duration on a treadmill. This protocol consists of a standardized gradual incremental increase in external workload every 3 minutes while the participant’s ECG, symptoms, and arm blood pressure were continuously monitored. The time of peak exercise was considered the time at which the participant reached at least one of the criteria for stopping the treadmill test (evidence of chest discomfort, severe shortness of breath, dizziness, fatigue, ST-segment depression of greater than 2 mm, a fall in systolic blood pressure exceeding 10 mmHg, or the development of a ventricular tachyarrhythmia). The ECG for that timepoint (time of peak exercise) was evaluated and the amount of ST segment depression was determined.
Time Frame 2.5 to approximately 2.75 hours post dose of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with evaluable data for assessment of ST segment depression at peak exercise available. Data from the 600 and 900 mg telcagepant treatments were grouped for comparsion to placebo.
Arm/Group Title Telcagepant Placebo
Hide Arm/Group Description:
Participants who received a single oral dose of 600 mg (or bioequivalent 560 mg tablets) or 900 mg telcagepant in Period 1 or 2 of crossover
Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
Overall Number of Participants Analyzed 57 55
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
-1.91
(-2.13 to -1.70)
-1.86
(-2.08 to -1.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant, Placebo
Comments Telcagepant minus Placebo Treatment Difference
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method mixed effects model
Comments mixed effects model with MK-0974 pooled over doses
Method of Estimation Estimation Parameter Difference in Least squares meand
Estimated Value -0.056
Confidence Interval (2-Sided) 90%
-0.19 to 0.076
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time to 1 mm ST Segment Depression
Hide Description Bruce (and Modified Bruce) Protocol was used to assess the exercise duration on a treadmill. This protocol consists of a standardized gradual incremental increase in external workload every 3 minutes while the participant’s ECG, symptoms, and arm blood pressure were continuously monitored. The ECG was reviewed and the time to the first ST segment depression of 1 mm was recorded.
Time Frame 2.5 to approximately 2.75 hours post dose of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants with evaluable data for assessment of time to 1 mm ST segment depression available. Data from the 600 and 900 mg telcagepant treatments were grouped for comparsion to placebo.
Arm/Group Title Telcagepant Placebo
Hide Arm/Group Description:
Participants who received a single oral dose of 600 mg (or bioequivalent 560 mg tablets) or 900 mg telcagepant in Period 1 or 2 of crossover
Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
Overall Number of Participants Analyzed 57 56
Least Squares Mean (95% Confidence Interval)
Unit of Measure: seconds
363.53
(330.78 to 396.27)
370.67
(337.85 to 403.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telcagepant, Placebo
Comments Telcagepant minus Placebo Treatment Difference
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method mixed effects model
Comments mixed effects model with MK-0974 pooled over doses
Method of Estimation Estimation Parameter Difference in Least Squares Means
Estimated Value -7.14
Confidence Interval (2-Sided) 90%
-22.03 to 7.74
Estimation Comments [Not Specified]
Time Frame Up to 10 days post dose in Period 1 and up to 14 days post dose in Period 2
Adverse Event Reporting Description AEs are reported by dose taken in a given treatment period and not by randomly assigned treatment sequence.
 
Arm/Group Title Telcagepant (600 mg) Telcagepant (900 mg) Placebo
Hide Arm/Group Description Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
All-Cause Mortality
Telcagepant (600 mg) Telcagepant (900 mg) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telcagepant (600 mg) Telcagepant (900 mg) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/16 (0.00%)   0/62 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telcagepant (600 mg) Telcagepant (900 mg) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   1/16 (6.25%)   0/62 (0.00%) 
General disorders       
Feeling Jittery  1  0/46 (0.00%)  1/16 (6.25%)  0/62 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 12.1
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.
Publications derived from this study should include input from the investigator(s), and SPONSOR personnel. The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01294709     History of Changes
Other Study ID Numbers: 0974-014
First Submitted: February 10, 2011
First Posted: February 11, 2011
Results First Submitted: September 3, 2014
Results First Posted: September 10, 2014
Last Update Posted: October 18, 2018