The Effect of PXR Activation on Blood Pressure Regulation

Blood Pressure Regulation Clinical Trial

Official title:

The Effect of PXR Activation on Blood Pressure Regulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690104
• Other study ID #: Rifa-BP
• Secondary ID: 2011-005522-22
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2012
• Last updated: December 29, 2014
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2012
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

• BMI 19-30 kg/m2

• Age 18-40 years

• Systolic blood pressure 95 - 140 mmHg

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Blood Pressure Regulation

Intervention

Drug:
• Rifampicin

• Placebo

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic ambulatory blood pressure	Systolic blood pressure measured with ambulatory blood pressure monitor.	On day 8 of each arm	No
Primary	Diastolic ambulatory blood pressure	Diastolic blood pressure measured with ambulatory blood pressure monitor	On day 8 of each arm	No
Secondary	Systolic and diastolic blood pressure		On day 9 of each arm	No
Secondary	Pulse (ambulatory)		On day 8 of each arm	No
Secondary	Plasma renin activity		On day 9 of each arm	No
Secondary	Serum aldosterone		On day 9 of each arm	No