Trial Outcomes & Findings for Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily? (NCT NCT03595982)
NCT ID: NCT03595982
Last Updated: 2022-06-30
Results Overview
Procardia plasma level at 24 hours after Procardia administration
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
5 participants
Primary outcome timeframe
at 24 hours
Results posted on
2022-06-30
Participant Flow
Participant milestones
| Measure |
Procardia XL 30 mg
Procardia XL 30 mg XL Q 12h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia XL divided in 2 doses of 30 mg given 12h apart.
Procardia XL 30Mg: Procardia XL 30 mg XL Q 12h
|
Procardia XL 60 mg
Procardia XL 60 mg Q 24h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia given once a day.
Procardia XL 60Mg: Procardia XL 60 mg Q 24h
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily?
Baseline characteristics by cohort
| Measure |
Procardia XL 30 mg
n=3 Participants
Procardia XL 30 mg XL Q 12h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia XL divided in 2 doses of 30 mg given 12h apart.
Procardia XL 30Mg: Procardia XL 30 mg XL Q 12h
|
Procardia XL 60 mg
n=2 Participants
Procardia XL 60 mg Q 24h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia given once a day.
Procardia XL 60Mg: Procardia XL 60 mg Q 24h
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 9 • n=5 Participants
|
35 years
STANDARD_DEVIATION 0 • n=7 Participants
|
38 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 24 hoursPopulation: Data not collected
Procardia plasma level at 24 hours after Procardia administration
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: up to 24 hoursBlood pressure reading
Outcome measures
| Measure |
Procardia XL 30 mg
n=3 Participants
Procardia XL 30 mg XL Q 12h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia XL divided in 2 doses of 30 mg given 12h apart.
Procardia XL 30Mg: Procardia XL 30 mg XL Q 12h
|
Procardia XL 60 mg
n=2 Participants
Procardia XL 60 mg Q 24h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia given once a day.
Procardia XL 60Mg: Procardia XL 60 mg Q 24h
|
|---|---|---|
|
Blood Pressure (Systolic/Diastolic)
Systolic
|
155 mmHg
Standard Deviation 14
|
146 mmHg
Standard Deviation 2
|
|
Blood Pressure (Systolic/Diastolic)
Diastolic
|
92 mmHg
Standard Deviation 10
|
84 mmHg
Standard Deviation 5
|
SECONDARY outcome
Timeframe: up to 24 hoursSurvey to assess Frequency of side effects of nifedipine including peripheral edema (most common side effect, dose related), flushing, headache, dizziness, fatigue, constipation, nausea, and muscle cramps.
Outcome measures
| Measure |
Procardia XL 30 mg
n=3 Participants
Procardia XL 30 mg XL Q 12h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia XL divided in 2 doses of 30 mg given 12h apart.
Procardia XL 30Mg: Procardia XL 30 mg XL Q 12h
|
Procardia XL 60 mg
n=2 Participants
Procardia XL 60 mg Q 24h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia given once a day.
Procardia XL 60Mg: Procardia XL 60 mg Q 24h
|
|---|---|---|
|
Survey of Side Effects
|
1 events
|
2 events
|
Adverse Events
Procardia XL 30 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Procardia XL 60 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Procardia XL 30 mg
n=3 participants at risk
Procardia XL 30 mg XL Q 12h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia XL divided in 2 doses of 30 mg given 12h apart.
Procardia XL 30Mg: Procardia XL 30 mg XL Q 12h
|
Procardia XL 60 mg
n=2 participants at risk
Procardia XL 60 mg Q 24h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia given once a day.
Procardia XL 60Mg: Procardia XL 60 mg Q 24h
|
|---|---|---|
|
Nervous system disorders
Headache
|
33.3%
1/3 • 24 hours
|
50.0%
1/2 • 24 hours
|
|
General disorders
Fatigue
|
0.00%
0/3 • 24 hours
|
50.0%
1/2 • 24 hours
|
Additional Information
Dr. Melissa Chu Lam
Icahn School of Medicine at Mount Sinai
Phone: 520-360-8807
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place