Hypertensive Ambulatory Trial to Compare the Efficacy of HCTZ and Lisinopril
1HAT
Series of Single Patient Trials Comparing the Efficacy Between the Most Commonly Prescribed Thiazide Diuretic in the US, Hydrochlorothiazide, and Lisinopril for the Treatment of Stage 1 Hypertension.
1 other identifier
interventional
2
1 country
1
Brief Summary
The purpose of this trial is to evaluate if an objective clinical decision of anti-hypertensive therapy can be made using an N-of-1 (single patient) trial design.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 9, 2010
CompletedFirst Posted
Study publicly available on registry
December 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedMay 20, 2015
May 1, 2015
3.3 years
December 9, 2010
May 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood pressure control defined as 24-hour ambulatory systolic and diastolic pressure average below 135/85 mmHg.
After 14 week study period with assessment of patient specific data
Secondary Outcomes (1)
Blood Pressure (BP) load, treatment of non-dippers, side effects, and compliance.
After 14 week study period with assessment of patient specific data
Study Arms (2)
Lisinopril
ACTIVE COMPARATORHydrochlorothiazide
ACTIVE COMPARATORInterventions
Lisinopril 10 mg oral, once daily for four week cycle and a 2 week cycle
Hydrochlorothiazide 25 mg oral, once daily for 4 week cycle and a 2 week cycle
Eligibility Criteria
You may qualify if:
- Diagnosis of Grade 1 Hypertension
- Treatment naïve
- GFR \> 60 within previous 3 months
- Urinary microalbumin level normal during previous 3 months
You may not qualify if:
- Pregnancy (Fetal morbidity and mortality may occur with the use of ACE inhibitors.)
- Uncontrolled Hyperthyroidism
- Sleep Apnea
- Primary Aldosteronism
- Renovascular Disease
- Cushing's Syndrome or steroid therapy
- No evidence of end organ damage
- EKG with evidence of LVH within previous 3 months
- Collagen Vascular Disease
- Current Smoker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Scripps Clinic
La Jolla, California, 92037, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bradley Patay, MD
Scripps Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Scripps Translational Science Institute
Study Record Dates
First Submitted
December 9, 2010
First Posted
December 13, 2010
Study Start
November 1, 2010
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
May 20, 2015
Record last verified: 2015-05