The Effect of PXR Activation on Blood Pressure Regulation
2 other identifiers
interventional
22
1 country
1
Brief Summary
We are investigating the effects of pregnane X receptor (PXR) activation on the regulation of blood pressure in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator) and placebo will be given for a week to volunteers and blood pressure is measured 24 hours using an ambulatory blood pressure monitor. Blood pressure regulating hormones will be measured in blood. Our hypothesis is that PXR is involved in the regulation of blood pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 7, 2012
CompletedFirst Posted
Study publicly available on registry
September 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 30, 2014
September 1, 2012
1.3 years
September 7, 2012
December 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Systolic ambulatory blood pressure
Systolic blood pressure measured with ambulatory blood pressure monitor.
On day 8 of each arm
Diastolic ambulatory blood pressure
Diastolic blood pressure measured with ambulatory blood pressure monitor
On day 8 of each arm
Secondary Outcomes (4)
Systolic and diastolic blood pressure
On day 9 of each arm
Pulse (ambulatory)
On day 8 of each arm
Plasma renin activity
On day 9 of each arm
Serum aldosterone
On day 9 of each arm
Study Arms (2)
Rifampicin
ACTIVE COMPARATORRifampicin 600 mg daily
Placebo
PLACEBO COMPARATORPlacebo daily
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers
- BMI 19-30 kg/m2
- Age 18-40 years
- Systolic blood pressure 95 - 140 mmHg
You may not qualify if:
- Any continuous medication
- Any significant medical condition as judged by the study physician
- Diastolic blood pressure over 90 mmHg
- Sensitivity to rifampicin
- Pregnancy and lactation
- Difficult venipuncture
- Abuse of alcohol or medications, or drug use.
- Participation in other trial with medications in previous 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oululead
- Oulu University Hospitalcollaborator
Study Sites (1)
Oulu University Hospital
Oulu, Finland
Related Publications (1)
Rahunen R, Kummu O, Koivukangas V, Hautajarvi H, Hakkola J, Rysa J, Hukkanen J. Pregnane X Receptor-4beta-Hydroxycholesterol Axis in the Regulation of Overweight- and Obesity-Induced Hypertension. J Am Heart Assoc. 2022 Mar 15;11(6):e023492. doi: 10.1161/JAHA.121.023492. Epub 2022 Mar 1.
PMID: 35229613DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janne Hukkanen, MD, PhD
Oulu University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2012
First Posted
September 21, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 30, 2014
Record last verified: 2012-09