A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension
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|ClinicalTrials.gov Identifier: NCT01658657|
Recruitment Status : Completed
First Posted : August 7, 2012
Results First Posted : June 22, 2015
Last Update Posted : August 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Plasma Renin Activity||Drug: Hydrochlorothiazide Drug: Lisinopril Drug: Amlodipine Drug: metoprolol Drug: lisinopril/hydrochlorothiazide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: 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.
|Drug: Hydrochlorothiazide Drug: Lisinopril Drug: Amlodipine Drug: metoprolol|
Active Comparator: 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.
This is a combination pill
- Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic [ Time Frame: 4 months ]At each study visit (approximately every 30 days), participants' BP will be checked. If BP is controlled (<140mmHG systolic and <90mmHG diastolic), then current medication will continue. If BP is uncontrolled, medication will be revised every 30 days (up to 120) until BP control is achieved.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658657
|United States, North Carolina|
|UNC Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Anthony Viera, MD, MPH||Distinguished Associate Professor, Family Medicine|