Pharmacogenomic Evaluation of Antihypertensive Responses 2 (PEAR2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01203852
First received: September 15, 2010
Last updated: April 29, 2015
Last verified: April 2015
Results First Received: April 29, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Metoprolol
Drug: Chlorthalidone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first subject was recruited on 8/10/10 and the final patient was recruited on 9/30/2013. Subjects were recruited from family medicine clinics and were identified through providers daily schedules, medical records, and encounter forms.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Healthy volunteers with mild to moderate primary hypertension between the ages of 18-70 were eligible for the study. Subjects were washed-out from their hypertension medication prior to beginning study protocol. Participants with elevated systolic blood pressure greater than 180 mmHg after wash-out were excluded from the study.

Reporting Groups
  Description
Metoprolol + Chlorthalidone

Metoprolol tartrate 50 mg twice daily for two weeks. After two weeks subjects will be seen in clinic and will have the dose doubled to 100 mg twice daily if either their home blood pressure (HBP) average or office blood pressure (OBP) is > 120/70 mmHg. They will continue on this dose for an additional 6 weeks. Then will washout from all study medication. After washout, participants will initiate chlorthalidone 25 mg four times per week (Monday, Wednesday, Thursday, Saturday) for two weeks, then 25 mg daily of chlorthalidone for 6 weeks.

Metoprolol: Metoprolol 50 mg twice daily titrated to 100 mg twice daily

Chlorthalidone: Chlorthalidone 25 mg 4 times per week titrated to 25 mg daily

Note: due to discontinuation of the manufacture of chlorthalidone 15 mg, effective Jan 1, 2013; the starting dose of chlorthalidone will be 25 mg 4 times per week (Mon, Wed, Thur, Sat) with subsequent titration to 25 mg daily.


Participant Flow:   Overall Study
    Metoprolol + Chlorthalidone  
STARTED     839  
COMPLETED     415  
NOT COMPLETED     424  
Withdrawal by Subject                 199  
Physician Decision                 225  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Approximately 1000 males or females with mild to moderate primary HTN, of any race or ethnicity, between the ages of 18 and 65 will be enrolled into the PEAR2 protocol. Prospective study participants will be those with newly diagnosed HTN, untreated HTN or known HTN currently treated with antihypertensive drugs.

Reporting Groups
  Description
Metoprolol + Chlorthalidone

Metoprolol tartrate 50 mg twice daily for two weeks. After two weeks subjects will be seen in clinic and will have the dose doubled to 100 mg twice daily if either their HBP average or OBP is > 120/70 mmHg. They will continue on this dose for an additional 6 weeks. Then will washout from all study medication. After washout, participants will initiate chlorthalidone 25 mg four times per week (Monday, Wednesday, Thursday, Saturday) for two weeks, then 25 mg daily of chlorthalidone for 6 weeks.

Metoprolol: Metoprolol 50 mg twice daily titrated to 100 mg twice daily

Chlorthalidone: Chlorthalidone 25 mg 4 times per week titrated to 25 mg daily

Note: due to discontinuation of the manufacture of chlorthalidone 15 mg, effective Jan 1, 2013; the starting dose of chlorthalidone will be 25 mg 4 times per week (Mon, Wed, Thur, Sat) with subsequent titration to 25 mg daily.


Baseline Measures
    Metoprolol + Chlorthalidone  
Number of Participants  
[units: participants]
  839  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     839  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  50.3  (9.0)  
Gender  
[units: participants]
 
Female     429  
Male     410  
Region of Enrollment  
[units: participants]
 
United States     839  



  Outcome Measures
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1.  Primary:   Antihypertensive Response   [ Time Frame: after 6-8 weeks of treatment ]

2.  Secondary:   Adverse Metabolic Effects   [ Time Frame: after 6-8 weeks treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Dr. Julie A. Johnson
Organization: University of Florida
phone: (352) 273-6309
e-mail: johnson@cop.ufl.edu


No publications provided


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01203852     History of Changes
Other Study ID Numbers: U01 GM074492-06
Study First Received: September 15, 2010
Results First Received: April 29, 2015
Last Updated: April 29, 2015
Health Authority: United States: Federal Government