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Trial record 23 of 143 for:    NIFEDIPINE

Oral Nifedipine Versus Oral Labetalol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168309
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Sarah Kilpatrick, Cedars-Sinai Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Severe Postpartum Hypertension
Interventions Drug: Labetalol
Drug: Nifedipine
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Labetalol Nifedipine
Hide Arm/Group Description

Labetalol 200mg PO BID starting dose

Labetalol: Titrate up for blood pressure control

Nifedpine XL starting at dose 30mg PO daily

Nifedipine: Titrate up to achieve blood pressure control

Period Title: Overall Study
Started 25 25
Completed 25 25
Not Completed 0 0
Arm/Group Title Labetalol Nifedipine Total
Hide Arm/Group Description

Labetalol 200mg PO BID starting dose

Labetalol: Titrate up for blood pressure control

Nifedpine XL starting at dose 30mg PO daily

Nifedipine: Titrate up to achieve blood pressure control

Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
25
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
34  (7.4) 33.3  (6.4) 33.7  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
25
 100.0%
25
 100.0%
50
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Hispanic or Latino
8
  32.0%
9
  36.0%
17
  34.0%
Not Hispanic or Latino
17
  68.0%
16
  64.0%
33
  66.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 25 participants 25 participants 50 participants
30.3  (4.1) 33.0  (7.8) 31.7  (6.0)
1.Primary Outcome
Title Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication
Hide Description Primary outcome
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Labetalol Nifedipine
Hide Arm/Group Description:

Labetalol 200mg PO BID starting dose

Labetalol: Titrate up for blood pressure control

Nifedpine XL starting at dose 30mg PO daily

Nifedipine: Titrate up to achieve blood pressure control

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: hours
37.6  (32.5) 38.2  (27.6)
2.Secondary Outcome
Title Total Length of Hospital Stay in Days
Hide Description Secondary outcome
Time Frame 0-10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Labetalol Nifedipine
Hide Arm/Group Description:

Labetalol 200mg PO BID starting dose

Labetalol: Titrate up for blood pressure control

Nifedpine XL starting at dose 30mg PO daily

Nifedipine: Titrate up to achieve blood pressure control

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: days
4.0  (1.5) 4.3  (2.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Labetalol Nifedipine
Hide Arm/Group Description

Labetalol 200mg PO BID starting dose

Labetalol: Titrate up for blood pressure control

Nifedpine XL starting at dose 30mg PO daily

Nifedipine: Titrate up to achieve blood pressure control

All-Cause Mortality
Labetalol Nifedipine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Labetalol Nifedipine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Labetalol Nifedipine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kathryn Sharma
Organization: Central Coast Perinatology
Phone: 8058980258
EMail: katy.jones@gmail.com
Layout table for additonal information
Responsible Party: Sarah Kilpatrick, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02168309     History of Changes
Other Study ID Numbers: Pro34034
First Submitted: June 17, 2014
First Posted: June 20, 2014
Results First Submitted: April 27, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017