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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study

Study Primary Completion Date: September 2006

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

Intervention(s) in this Clinical Trial

• 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
• 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

Arms, Groups and Cohorts in this Clinical Trial

• 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
• 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

Primary Measures

• Arterial blood pressure
  • Time Frame: 3 months (3 individual blocks of 1 month each)
    Safety Issue?: Yes

Secondary Measures

• Body weight,serum electrolytes, urinary electrolytes (Na, K)
  • Time Frame: 3 months (3 periods of 1 month)
    Safety Issue?: Yes

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 78 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Split

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00631514

Study ID Number: 1-Pavlicevic

ClinicalTrials.gov Identifier: NCT00631514

Health Authority: Croatia: National Ethics Committee; Zagreb, Croatia

Split University School of Medicine