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Trial record 12 of 15 for:    Hydrochlorothiazide AND metoprolol succinate

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
Sponsor:
Collaborators:
Cornell University
Wake Forest University Health Sciences
Information provided by (Responsible Party):
Anthony J Viera, MD, MPH, University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hypertension
Plasma Renin Activity
Interventions Drug: Hydrochlorothiazide
Drug: Lisinopril
Drug: Amlodipine
Drug: metoprolol
Drug: lisinopril/hydrochlorothiazide
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PRA-guided Therapy Fixed-dose Combination Treatment-guided Therapy
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 7 10
Completed 4 7
Not Completed 3 3
Arm/Group Title PRA-guided Therapy Fixed-dose Combination Treatment-guided Therapy Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 7 10 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants 10 participants 17 participants
47.6
(35 to 59)
46.7
(27 to 67)
47
(27 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 17 participants
Female
2
  28.6%
5
  50.0%
7
  41.2%
Male
5
  71.4%
5
  50.0%
10
  58.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 10 participants 17 participants
7 10 17
1.Primary Outcome
Title Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic
Hide Description 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.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
6 participants withdrawn before study completion
Arm/Group Title PRA-guided Therapy Fixed-dose Combination Treatment-guided Therapy
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 4 7
Measure Type: Number
Unit of Measure: participants
3 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PRA-guided Therapy Fixed-dose Combination Treatment-guided Therapy
Hide Arm/Group Description

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

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

All-Cause Mortality
PRA-guided Therapy Fixed-dose Combination Treatment-guided Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PRA-guided Therapy Fixed-dose Combination Treatment-guided Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PRA-guided Therapy Fixed-dose Combination Treatment-guided Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/7 (42.86%)      4/10 (40.00%)    
Blood and lymphatic system disorders     
Electrolyte disturbance   2/7 (28.57%)  2 2/10 (20.00%)  2
General disorders     
Lightheadedness   1/7 (14.29%)  1 2/10 (20.00%)  2
Indicates events were collected by systematic assessment
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
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
First Submitted: July 31, 2012
First Posted: August 7, 2012
Results First Submitted: June 3, 2015
Results First Posted: June 22, 2015
Last Update Posted: August 27, 2015