Blood Pressure RegulationPhase 4NCT01690104
The Effect of PXR Activation on Blood Pressure Regulation
A Phase 4 study testing Rifampicin in people with Blood Pressure Regulation, run by University of Oulu at 1 site in Finland.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure Regulation
- What is being tested?
- Rifampicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2012to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- BMI 19-30 kg/m2
- Age 18-40 years
- Systolic blood pressure 95 - 140 mmHg
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Blood Pressure Regulation
- Being tested
- Rifampicin, Placebo
- Keywords
- rifampicin, pregnane X receptor, blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifampicinDrug
Also called Rimapen
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Rifampicin | Active comparator | Rifampicin 600 mg daily Receives: Drug: Rifampicin |
| Placebo | Placebo comparator | Placebo daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic ambulatory blood pressure
Systolic blood pressure measured with ambulatory blood pressure monitor.
Measured: On day 8 of each arm
Diastolic ambulatory blood pressure
Diastolic blood pressure measured with ambulatory blood pressure monitor
Measured: On day 8 of each arm
Secondary outcomes (4)
Systolic and diastolic blood pressure
Measured: On day 9 of each arm
Pulse (ambulatory)
Measured: On day 8 of each arm
Plasma renin activity
Measured: On day 9 of each arm
Serum aldosterone
Measured: On day 9 of each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood Pressure RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital
- Responsible party
- Sponsor
- Investigators
- Janne Hukkanen, MD, PhD, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690104
- Sponsor's protocol ID
- Rifa-BP
- Other IDs
- 2011-005522-22
- Status last verified
- Sep 2012
- First submitted
- 7 Sep 2012
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rahunen R, Merikallio H, Rinne V, Savolainen MJ, Hukkanen J. Hypertension in Overweight and Obesity: Sex-Specific Role of 4beta-Hydroxycholesterol. J Am Heart Assoc. 2026 Mar 3;15(5):e043913. doi: 10.1161/JAHA.125.043913. Epub 2026 Feb 26.
PubMed 41744113Rahunen 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.
PubMed 35229613
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of PXR Activation on Blood Pressure Regulation
- ClinicalTrials.gov ID
- NCT01690104
- Acronym / sponsor ID
- Rifa-BP
- Conditions
- Blood Pressure Regulation
- Keywords
- rifampicin, pregnane X receptor, blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifampicin | Active comparator | Drug: RifampicinRifampicin 600 mg daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo daily |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers
- BMI 19-30 kg/m2
- Age 18-40 years
- Systolic blood pressure 95 - 140 mmHg
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RifampicinAlso: Rimapen | Drug | Rifampicin |
| Placebo | Drug | Placebo |
Primary outcome
Systolic ambulatory blood pressure
Time frame: On day 8 of each arm
Systolic blood pressure measured with ambulatory blood pressure monitor.
Diastolic ambulatory blood pressure
Time frame: On day 8 of each arm
Diastolic blood pressure measured with ambulatory blood pressure monitor
4 secondary outcomes
Systolic and diastolic blood pressure
Time frame: On day 9 of each arm
Pulse (ambulatory)
Time frame: On day 8 of each arm
Plasma renin activity
Time frame: On day 9 of each arm
Serum aldosterone
Time frame: On day 9 of each arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
- Derived from this study: PubMed 41744113Rahunen R, Merikallio H, Rinne V, Savolainen MJ, Hukkanen J. Hypertension in Overweight and Obesity: Sex-Specific Role of 4beta-Hydroxycholesterol. J Am Heart Assoc. 2026 Mar 3;15(5):e043913. doi: 10.1161/JAHA.125.043913. Epub 2026 Feb 26.
- Derived from this study: PubMed 35229613Rahunen 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.
Related trials for Blood Pressure Regulation
Recruiting
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
Poor Sleep Quality, Gut Microbiome
Not yet recruiting
Investigating Sex Differences in Mitochondrial Function and Leg Blood Flow During Exercise
Healthy Adult Male, Healthy Adult Females
Recruiting
Time-Efficient Inspiratory Muscle Strength Training for Reducing Sympathetic Activity and Improving Sleep in Midlife Women
Menopause, Hot Flashes
Active, not recruiting
The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes
Type 2 Diabetes Mellitus, Obesity
Not yet recruiting
The Effects of Nitrate-Rich Mouthwash on Vascular Tone
Blood Pressure Regulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janne Hukkanen, MD, PhD principal investigator
Oulu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifampicin in people with Blood Pressure Regulation, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic ambulatory blood pressure (time frame: On day 8 of each arm). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01690104, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.