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The Effect of PXR Activation on Blood Pressure Regulation

This study is currently recruiting participants.
Verified September 2012 by University of Oulu
Sponsor:
Collaborator:
Oulu University Hospital
Information provided by (Responsible Party):
University of Oulu
ClinicalTrials.gov Identifier:
NCT01690104
First received: September 7, 2012
Last updated: September 17, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Blood Pressure Regulation
 Drug: Rifampicin
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of PXR Activation on Blood Pressure Regulation

Resource links provided by NLM:

Drug Information available for: Rifampin
U.S. FDA Resources

Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Systolic ambulatory blood pressure [ Time Frame: On day 8 of each arm ] [ Designated as safety issue: No ]
    Systolic blood pressure measured with ambulatory blood pressure monitor.

  • Diastolic ambulatory blood pressure [ Time Frame: On day 8 of each arm ] [ Designated as safety issue: No ]
    Diastolic blood pressure measured with ambulatory blood pressure monitor


Secondary Outcome Measures:
  • Systolic and diastolic blood pressure [ Time Frame: On day 9 of each arm ] [ Designated as safety issue: No ]
  • Pulse (ambulatory) [ Time Frame: On day 8 of each arm ] [ Designated as safety issue: No ]
  • Plasma renin activity [ Time Frame: On day 9 of each arm ] [ Designated as safety issue: No ]
  • Serum aldosterone [ Time Frame: On day 9 of each arm ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rifampicin
Rifampicin 600 mg daily
 Drug: Rifampicin
Other Name: Rimapen
Placebo Comparator: Placebo
Placebo daily
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690104

Contacts
Contact: Janne Hukkanen, MD, PhD 35883156212 janne.hukkanen@oulu.fi

Locations
Finland
Oulu University Hospital Recruiting
Oulu, Finland
Contact: Janne Hukkanen, MD, PhD     35883156212     janne.hukkanen@oulu.fi    
Principal Investigator: Janne Hukkanen, MD, PhD            
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
Investigators
Principal Investigator: Janne Hukkanen, MD, PhD Oulu University Hospital
  More Information

No publications provided

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT01690104     History of Changes
Other Study ID Numbers: Rifa-BP, 2011-005522-22
Study First Received: September 7, 2012
Last Updated: September 17, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by University of Oulu:
rifampicin
pregnane X receptor
blood pressure

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013