HypertensionPhase 4NCT00631514
Interaction Between Antihypertensives and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
A Phase 4 study testing acetaminophen, ibuprofen and piroxicam in people with Hypertension, run by University of Split at 1 site in Croatia.
Trial summary
NSAIDs may increase blood pressure and blunt the effects of many antihypertensives. Members of these drug classes differ in their propensity to such an interaction. Read more about this study
- Who is it for?
- Ages 55 to 78 years
- Conditions the study is for
- Hypertension
- What is being tested?
- acetaminophen, ibuprofen and piroxicam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteCroatia
- Study dates
- Jan 2005to Sep 2006
- 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 55 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treated hypertensives of either gender aged between 55 and 76 years
- About 50% with concomitant osteoarthritis of the hip or knee
Who cannot join
- Normotensive persons or untreated hypertensives
- Individuals outside the age limits
- General exclusion criteria (e.g. uncooperative persons, advanced malignancies, participants in other studies)
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Split University School of Medicine. Family Practice Department
Split, 21000
About this study
Official title: Relevance of the Interaction Between Antihypertensive and Antirheumatic Drugs in a Family Practice
NSAIDs may increase blood pressure and blunt the effects of many antihypertensives. Members of these drug classes differ in their propensity to such an interaction.
Read the detailed description
To compare prospectively the effects of piroxicam, ibuprofen and acetaminophen on blood pressure control in hypertensive patients with osteoarthritis.
- Conditions
- Hypertension
- Being tested
- acetaminophen, ibuprofen, piroxicam
- Keywords
- antihypertensive drugs, non-steroidal anti-inflammatory drugs, interaction, family practice, arterial blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophenDrug
Also called paracetamol
acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os
ibuprofenDrug
acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os
piroxicamDrug
acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Hypertensive persons taking either lisinopril/hydrochlorothiazide fixed combination or amlodipine all the time. |
| 2 | Experimental | Intervention: NSAID. Hypertensives with osteoarthritis taking already amlodipine (5-10 mg o.d. per os) were randomized to the following drug interventions: to take either acetaminophen (1000 mg t.i.d. per os), piroxicam (10-20 mg o.d. per os) or ibuprofen (400-600 mg t.i.d. per os) for 1 month Receives: Drug: acetaminophen; Drug: ibuprofen; Drug: piroxicam |
| 3 | Experimental | Hypertensives with osteoarthritis taking already lisinopril/hydrochlorothiazide (20/12.5 mg o.d. per os), were sequentially randomized to the following drug interventions: acetaminophen (1000 mg t.i.d.), ibuprofen (400-600 mg t.i.d.) or piroxicam (10-20 mg o.d.), for 1 month each Receives: Drug: acetaminophen; Drug: ibuprofen; Drug: piroxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood pressure
Measured: 3 months (3 individual blocks of 1 month each)
Secondary outcomes (1)
Body weight,serum electrolytes, urinary electrolytes (Na, K)
Measured: 3 months (3 periods of 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startJan 2005
- Primary completionSep 2006
- Study completionSep 2006
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 HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Split
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Ivancica Pavlicevic Family Practice Office
- Investigators
- Zvonko - Rumboldt, MD, PhD, Study director, Split University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631514
- Sponsor's protocol ID
- 1-Pavlicevic
- Status last verified
- Feb 2008
- First submitted
- 27 Feb 2008
- Last updated
- 10 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Pavlicevic I, Rumboldt M, Rumboldt Z. [Untoward interactions between antihypertensives and nonsteroidal anti-inflammatory drugs]. Lijec Vjesn. 2005 Jul-Aug;127(7-8):168-72. Croatian.
PubMed 16485829Pavlicevic I, Kuzmanic M, Rumboldt M, Rumboldt Z. Interaction between antihypertensives and NSAIDs in primary care: a controlled trial. Can J Clin Pharmacol. 2008 Fall;15(3):e372-82. Epub 2008 Oct 24.
PubMed 18953082
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of the Interaction Between Antihypertensive and Antirheumatic Drugs in a Family Practice
- ClinicalTrials.gov ID
- NCT00631514
- Acronym / sponsor ID
- 1-Pavlicevic
- Conditions
- Hypertension
- Keywords
- antihypertensive drugs, non-steroidal anti-inflammatory drugs, interaction, family practice, arterial blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of SplitUniversity, hospital or other
- Collaborators
- Dr Ivancica Pavlicevic Family Practice Office
- Study start
- Jan 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 7 Mar 2008 (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.
NSAIDs may increase blood pressure and blunt the effects of many antihypertensives. Members of these drug classes differ in their propensity to such an interaction.
Detailed description
To compare prospectively the effects of piroxicam, ibuprofen and acetaminophen on blood pressure control in hypertensive patients with osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Hypertensive persons taking either lisinopril/hydrochlorothiazide fixed combination or amlodipine all the time. |
| 2 | Experimental | Drug: acetaminophen, Drug: ibuprofen, Drug: piroxicamIntervention: NSAID. Hypertensives with osteoarthritis taking already amlodipine (5-10 mg o.d. per os) were randomized to the following drug interventions: to take either acetaminophen (1000 mg t.i.d. per os), piroxicam (10-20 mg o.d. per os) or ibuprofen (400-600 mg t.i.d. per os) for 1 month |
| 3 | Experimental | Drug: acetaminophen, Drug: ibuprofen, Drug: piroxicamHypertensives with osteoarthritis taking already lisinopril/hydrochlorothiazide (20/12.5 mg o.d. per os), were sequentially randomized to the following drug interventions: acetaminophen (1000 mg t.i.d.), ibuprofen (400-600 mg t.i.d.) or piroxicam (10-20 mg o.d.), for 1 month each |
Who may qualify
- Ages
- 55 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Treated hypertensives of either gender aged between 55 and 76 years
- About 50% with concomitant osteoarthritis of the hip or knee
Key exclusion criteria (3 listed)
- Normotensive persons or untreated hypertensives
- Individuals outside the age limits
- General exclusion criteria (e.g. uncooperative persons, advanced malignancies, participants in other studies)
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 |
|---|---|---|
| acetaminophenAlso: paracetamolacetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os | Drug | 2, 3 |
| ibuprofenacetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os | Drug | 2, 3 |
| piroxicamacetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os | Drug | 2, 3 |
Primary outcome
Arterial blood pressure
Time frame: 3 months (3 individual blocks of 1 month each)
1 secondary outcome
Body weight,serum electrolytes, urinary electrolytes (Na, K)
Time frame: 3 months (3 periods of 1 month)
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 10 Mar 2008.
- Background: PubMed 16485829Pavlicevic I, Rumboldt M, Rumboldt Z. [Untoward interactions between antihypertensives and nonsteroidal anti-inflammatory drugs]. Lijec Vjesn. 2005 Jul-Aug;127(7-8):168-72. Croatian.
- Derived from this study: PubMed 18953082Pavlicevic I, Kuzmanic M, Rumboldt M, Rumboldt Z. Interaction between antihypertensives and NSAIDs in primary care: a controlled trial. Can J Clin Pharmacol. 2008 Fall;15(3):e372-82. Epub 2008 Oct 24.
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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.
Zvonko - Rumboldt, MD, PhD study director
Split University School of Medicine
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 acetaminophen, ibuprofen and piroxicam in people with Hypertension, run by University of Split at 1 site in Croatia.
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 2 inclusion and 3 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 10 Mar 2008. 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 Croatia. 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. 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?
Arterial blood pressure (time frame: 3 months (3 individual blocks of 1 month each)). 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 NCT00631514, 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 10 Mar 2008.