Default BP Medication Intensification
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ClinicalTrials.gov Identifier: NCT01994408 |
Recruitment Status :
Terminated
(slow enrollment)
First Posted : November 25, 2013
Last Update Posted : February 1, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Other: default intensification | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | default drug escalation |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Automatic Medication Increase Protocol in the Treatment of Elevated Blood Pressure |
Study Start Date : | November 2013 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: default intensification arm (all)
all subjects will receive blister packs with weekly increasing blood pressure medications. There is no control arm for this study
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Other: default intensification
The investigators will determine which blood pressure medications to use. No specific drug will be tested but rather the automatic intensification of medications is the intervention. Examples of drugs used in this study are calcium channel blockers (e.g., amlodipine 2.5 mg to 10 mg) or ACE-inhibitors (e.g., lisinopril 5 mg to 40 mg) or diuretics (HCTZ 25 mg).
Other Name: weekly increasing blood pressure medications. |
- Symptomatic hypotension [ Time Frame: from enrollment to 12 weeks ]Primary safety outcome is symptomatic hypotension during study participation (12 weeks). Safety monitoring will be achieved with patient-directed iPhone-based BP measuring and transmitting to study staff.
- hypertension control rate [ Time Frame: at 12 weeks ]The investigators will assess blood pressure throughout the study period (12 weeks) with iPhone based technology. Hypertension control is defined as home blood pressure <135/85 mmHg

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 to 55 years old
- office BP of ≥160 mmHg systolic and ≥100 mmHg diastolic (treated or untreated) AND <180 mmHg systolic.
Exclusion Criteria:
- chronic kidney disease
- symptomatic coronary artery disease
- congestive heart failure
- more than mild valvular heart disease
- Diabetes mellitus
- obstructive left ventricular hypertrophy
- severe electrolyte abnormalities
- multiple medication intolerances
- orthostatic hypotension
- cognitive impairment and mental disorders affecting ability to self-monitor BP
- patients who are unwilling to measure and transmit BP readings throughout the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994408
United States, California | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 |
Principal Investigator: | Florian Rader, MD | Cedars-Sinai Medical Center |
Responsible Party: | Florian Rader, MD, MSc, Assistant Professor, Cedars-Sinai Medical Center |
ClinicalTrials.gov Identifier: | NCT01994408 |
Other Study ID Numbers: |
Pro00030558 |
First Posted: | November 25, 2013 Key Record Dates |
Last Update Posted: | February 1, 2017 |
Last Verified: | January 2017 |
physician inertia hypertension telemedicine mobile technology |
Hypertension Vascular Diseases Cardiovascular Diseases |