The Precision Hypertension Care study
- Conditions
- HypertensionTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2015-003049-24-SE
- Lead Sponsor
- ppsala University, Department of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
1. Male or female aged =40 years and =75 years
2. Previously diagnosed with hypertension with systolic blood pressure between 140 and 159 mm Hg within five years prior to the start of the trial.
3. Pharmacologically untreated or using blood pressure-lowering monotherapy at Visit 1. No blood pressure-lowering medication taken during the placebo run-in period.
4. Office systolic blood pressure between 140 and 179 mm Hg and diastolic blood pressure at or below 109 mm Hg at Visit 2.
5. Patients must give informed consent to participate in the study.
6 Access to a smartphone.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
1. Medical history, clinical signs or laboratory results indicating secondary hypertension.
2. Evidence of serious hematological, respiratory immunological, renal, hepatic, gastrointestinal, endocrinological, metabolic, neurologic, malignant, psychiatric or other diseases as revealed by medical history, physical examination and/or laboratory assessments.
3. Lithium treatment and gout.
4. Previous or present arterial occlusive diseases such as myocardial infarction (MI), stroke or acute arterial insufficiency (unstable angina pectoris or transient ischemic attacks, (TIA)) or heart failure (NYHA class III or IV).
5. Symptomatic hypotension, defined as weakness or syncope upon rising to an erect position associated with a decrease in systolic blood pressure.
6. Patients with diabetes requiring insulin or oral glucose-lowering drugs.
7. Patients with history of serious abnormal drug reaction including angioedema.
8. Patients with any condition associated with poor compliance including alcoholism or drug dependence.
9. Patients who will not comply with the study protocol as judged by the Investigator.
10. Women who are pregnant or lactating or not using appropriate contraception for at least 3 months prior to visit 1.
11. Patient using concomitant medication that can interfere with study medication, and that according to FASS should not be given.
12. Clinical laboratory assessment outside normal range at visit 1 as judged by Investigator.
13. Previous enrolment in present study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method