A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension

This study has been completed.
Sponsor:
Collaborators:
Cornell University
Wake Forest School of Medicine
Information provided by (Responsible Party):
Anthony J Viera, MD, MPH, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01658657
First received: July 31, 2012
Last updated: August 17, 2015
Last verified: August 2015
Results First Received: June 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hypertension
Plasma Renin Activity
Interventions: Drug: Hydrochlorothiazide
Drug: Lisinopril
Drug: Amlodipine
Drug: metoprolol
Drug: lisinopril/hydrochlorothiazide

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PRA-guided Therapy

Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.

Hydrochlorothiazide

Lisinopril

Amlodipine

metoprolol

Fixed-dose Combination Treatment-guided Therapy

Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.

Amlodipine

metoprolol

lisinopril/hydrochlorothiazide


Participant Flow:   Overall Study
    PRA-guided Therapy     Fixed-dose Combination Treatment-guided Therapy  
STARTED     7     10  
COMPLETED     4     7  
NOT COMPLETED     3     3  



  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.
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Reporting Groups
  Description
PRA-guided Therapy

Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.

Hydrochlorothiazide

Lisinopril

Amlodipine

metoprolol

Fixed-dose Combination Treatment-guided Therapy

Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.

Amlodipine

metoprolol

lisinopril/hydrochlorothiazide

Total Total of all reporting groups

Baseline Measures
    PRA-guided Therapy     Fixed-dose Combination Treatment-guided Therapy     Total  
Number of Participants  
[units: participants]
  7     10     17  
Age  
[units: years]
Mean (Full Range)
  47.6   (35 to 59)     46.7   (27 to 67)     47   (27 to 67)  
Gender  
[units: participants]
     
Female     2     5     7  
Male     5     5     10  
Region of Enrollment  
[units: participants]
     
United States     7     10     17  



  Outcome Measures

1.  Primary:   Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic   [ Time Frame: 4 months ]


  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: Anthony Viera
Organization: UNC Chapel Hil
phone: 919-966-0758
e-mail: viera@med.unc.edu


No publications provided


Responsible Party: Anthony J Viera, MD, MPH, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01658657     History of Changes
Other Study ID Numbers: 12-1133
Study First Received: July 31, 2012
Results First Received: June 3, 2015
Last Updated: August 17, 2015
Health Authority: United States: Institutional Review Board