Interaction Between Antihypertensives and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

March 7, 2008 updated by: University Hospital of Split

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To compare prospectively the effects of piroxicam, ibuprofen and acetaminophen on blood pressure control in hypertensive patients with osteoarthritis.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Split, Croatia, 21000
        • Split University School of Medicine. Family Practice Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

53 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Treated hypertensives of either gender aged between 55 and 76 years
  • About 50% with concomitant osteoarthritis of the hip or knee

Exclusion Criteria:

  • Normotensive persons or untreated hypertensives
  • Individuals outside the age limits
  • General exclusion criteria (e.g. uncooperative persons, advanced malignancies, participants in other studies)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Hypertensive persons taking either lisinopril/hydrochlorothiazide fixed combination or amlodipine all the time.
Experimental: 2
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
Drug: acetaminophen
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
Other Names:
  • paracetamol
Drug: ibuprofen
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
Drug: piroxicam
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
Experimental: 3
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
Drug: acetaminophen
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
Other Names:
  • paracetamol
Drug: ibuprofen
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
Drug: piroxicam
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Arterial blood pressure
Time Frame: 3 months (3 individual blocks of 1 month each)
3 months (3 individual blocks of 1 month each)

Secondary Outcome Measures

Outcome Measure
Time Frame
Body weight,serum electrolytes, urinary electrolytes (Na, K)
Time Frame: 3 months (3 periods of 1 month)
3 months (3 periods of 1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Split

Collaborators

Dr Ivancica Pavlicevic Family Practice Office

Investigators

  • Study Director: Zvonko - Rumboldt, MD, PhD, Split University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

March 10, 2008

Last Update Submitted That Met QC Criteria

March 7, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-Pavlicevic

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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