The Effect of PXR Activation on Blood Pressure Regulation

December 29, 2014 updated by: University of Oulu
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland
        • Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rifampicin
Rifampicin 600 mg daily
Drug: Rifampicin
Other Names:
  • Rimapen
Placebo Comparator: Placebo
Placebo daily
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic ambulatory blood pressure
Time Frame: On day 8 of each arm
Systolic blood pressure measured with ambulatory blood pressure monitor.
On day 8 of each arm
Diastolic ambulatory blood pressure
Time Frame: On day 8 of each arm
Diastolic blood pressure measured with ambulatory blood pressure monitor
On day 8 of each arm

Secondary Outcome Measures

Outcome Measure
Time Frame
Systolic and diastolic blood pressure
Time Frame: On day 9 of each arm
On day 9 of each arm
Pulse (ambulatory)
Time Frame: On day 8 of each arm
On day 8 of each arm
Plasma renin activity
Time Frame: On day 9 of each arm
On day 9 of each arm
Serum aldosterone
Time Frame: On day 9 of each arm
On day 9 of each arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Collaborators

Oulu University Hospital

Investigators

  • Principal Investigator: Janne Hukkanen, MD, PhD, Oulu University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 7, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rifa-BP
  • 2011-005522-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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