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Mechanisms of Refractory Hypertension (Reserpine)

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ClinicalTrials.gov Identifier: NCT03223272
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
David Calhoun, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE July 17, 2017
First Posted Date  ICMJE July 21, 2017
Last Update Posted Date July 27, 2018
Actual Study Start Date  ICMJE July 23, 2015
Estimated Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
Ambulatory Systolic Blood Pressure [ Time Frame: 8 weeks ]
Twenty-four ambulatory systolic blood pressure
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03223272 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mechanisms of Refractory Hypertension (Reserpine)
Official Title  ICMJE Mechanisms of Refractory Hypertension (Reserpine)
Brief Summary The study is deigned to determine if refractory hypertension is attributable to heightened sympathetic tone by quantifying the antihypertensive benefit of reserpine, a sympatholytic agent, in patients failing other classes of antihypertensive agents.
Detailed Description Patients with refractory hypertension, defined as uncontrolled office blood pressure despite use of 5 or more antihypertensive agents, including a thiazide diuretic and spironolactone, will be randomized to open-label reserpine 0.1 mg daily for 4 weeks. If tolerated, the dose of the reserpine will be increased to 0.25 mg daily for an additional 4 weeks. Twenty-four hour ambulatory blood pressure monitoring will be done at baseline, after the initial 4-week treatment period, and at the end of the 8-week treatment period. All other antihypertensive medications will remain unchanged during the 8-week treatment period. The primary endpoint will be change in 24-hr ambulatory systolic blood pressure.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Open-label, dose titration study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Refractory Hypertension
Intervention  ICMJE Drug: Reserpine
Open label reserpine 0.1-0.25 mg pill orally
Study Arms  ICMJE Experimental: Reserpine
Subjects will receive open-label reserpine 0.1 mg daily for - weeks; titrating to 0.25 mg daily for additional 4-weeks
Intervention: Drug: Reserpine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2019
Estimated Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- adult with refractory hypertension defined as uncontrolled office blood pressure with use of 5 or more hypertensive agents, including a thiazide diuretic and spironolactone

Exclusion Criteria:

  • congestive heart failure (EF 40%)
  • chronic kidney disease (GFR <40 ml/min/1.73 mm)
  • stroke and/or myocardial infarction or acute CHF exacerbation within last 3 months
  • ongoing depression
  • active peptic ulcer disease
  • bradycardia <50 beats per minute
  • 2nd or 3rd degree heart block
  • known intolerance of reserpine
  • use of digoxin or tricycle antidepressants
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David A Calhoun, MD 205-934-9281 dcalhoun@uab.edu
Contact: Felice Y Cook, BA 205-934-1400 fycook@uab.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03223272
Other Study ID Numbers  ICMJE 130822008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: One year after study completion, de-identified subject demographic data and primary outcome data will be available by request.
Supporting Materials: Study Protocol
Time Frame: One year after study completion
Access Criteria: By request.
Responsible Party David Calhoun, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David A Calhoun, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP