NL-OMON39868CompletedPhase 3
ROX CONTROL HTN Study: A Prospective, Randomized, Open-Label, Multicenter Study to Evaluate the ROX Coupler in Patients with Resistant Hypertension - ROX CONTROL HT
Clinical Department0 sites15 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 15
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1. Office Systolic blood pressure >= 140 mmHg based on an average of 3 blood pressure readings;2. Ambulatory Blood Pressure Monitoring (ABPM) daytime average:
- •Systolic blood pressure (SBP) >= 135 mmHg;
- •Diastolic blood pressure (DBP) >= 85 mmHg ;See Protocol Section 4.4.1 for complete Inclusion Criteria
Exclusion Criteria
- •1. Secondary hypertension attributable to a cause other than sleep apnea
- •2. Type I diabetes
- •See Protocol Section 4.4.2 for complete Exclusion Criteria
Investigators
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