The Effect of PXR Activation on Blood Pressure Regulation

NCT ID: NCT01690104

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Pressure Regulation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

rifampicin pregnane X receptor blood pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rifampicin

Rifampicin 600 mg daily

Group Type ACTIVE_COMPARATOR

Rifampicin

Intervention Type DRUG

Placebo

Placebo daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rifampicin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rimapen

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oulu University Hospital

OTHER

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Janne Hukkanen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oulu University Hospital

Oulu, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35229613 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011-005522-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Rifa-BP

Identifier Type: -

Identifier Source: org_study_id