Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
16 December 2017 |
Main ID: |
NCT02623036 |
Date of registration:
|
19/11/2015 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
The Use of Ambulatory Blood Pressure Monitors to Assess Angiotensin Converting Enzyme Inhibitors
|
Scientific title:
|
The Use of Ambulatory Blood Pressure Monitors to Assess Angiotensin Converting Enzyme Inhibitors in Resistant Hypertension |
Date of first enrolment:
|
November 2015 |
Target sample size:
|
20 |
Recruitment status: |
Recruiting |
URL:
|
https://clinicaltrials.gov/show/NCT02623036 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
Phase:
|
Phase 1
|
|
Countries of recruitment
|
United States
| | | | | | | |
Contacts
|
Name:
|
John Bucheit, Pharm.D. |
Address:
|
|
Telephone:
|
312-350-8404 |
Email:
|
bucheit_jd@mercer.edu |
Affiliation:
|
|
|
Name:
|
John D. Bucheit, Pharm D |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Memorial Health University Medical Center |
|
Name:
|
John D Bucheit, Pharm.D. |
Address:
|
|
Telephone:
|
912-350-8404 |
Email:
|
bucheit_jd@mercer.edu |
Affiliation:
|
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients with clinic blood pressure > 140/90 mm Hg on 3 antihypertensives or clinic
blood pressure < 140/90 mm Hg on 4 antihypertensives
- Currently treated with an angiotensin converting enzyme inhibitor
Exclusion Criteria:
- Chronic kidney disease (CKD) stage 4 or worse
- Pheochromocytoma
- Unstable cardiovascular disease Stroke, Transient Ischemic Attack, Unstable Angina, or
Myocardial infarction in the last 30 days
- Hyperaldosteronism
- Current pregnancy
- Shift worker at night
- Presenting blood pressure > 180/110 mm Hg
Age minimum:
18 Years
Age maximum:
79 Years
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Hypertension, Resistant to Conventional Therapy
|
Intervention(s)
|
Drug: Equivalent dose lisinopril
|
Drug: Equivalent dose enalapril
|
Primary Outcome(s)
|
Change from baseline nighttime blood pressure
[Time Frame: Baseline and 4-6 weeks]
|
Secondary Outcome(s)
|
Change from baseline 24 Hour Blood Pressure
[Time Frame: Baseline and 4-6 weeks]
|
Change from baseline night to day blood pressure ratio (dipping status)
[Time Frame: Baseline and 4-6 weeks]
|
Secondary ID(s)
|
MHUMC 2015.10.01
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|