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Completed

NCT Number: NCT01690104

The Effect of PXR Activation on Blood Pressure Regulation

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.

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Key information

Conditions

Blood Pressure Regulation

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oulu University Hospital

Oulu, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rifampicin

Drug

Other names: Rimapen

Placebo

Drug

Primary outcomes

  1. Systolic ambulatory blood pressure

    Time frame: On day 8 of each arm

    Systolic blood pressure measured with ambulatory blood pressure monitor.

  2. Diastolic ambulatory blood pressure

    Time frame: On day 8 of each arm

    Diastolic blood pressure measured with ambulatory blood pressure monitor

Secondary outcomes

  1. Systolic and diastolic blood pressure

    Time frame: On day 9 of each arm

  2. Pulse (ambulatory)

    Time frame: On day 8 of each arm

  3. Plasma renin activity

    Time frame: On day 9 of each arm

  4. Serum aldosterone

    Time frame: On day 9 of each arm

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Oulu University Hospital

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 21, 2012
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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