Default BP Medication Intensification
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01994408|
Recruitment Status : Terminated (slow enrollment)
First Posted : November 25, 2013
Last Update Posted : February 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Other: default intensification||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||default drug escalation|
|Masking:||None (Open Label)|
|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|
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
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
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|