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

This study has been completed.
Sponsor:
Collaborator:
Dr Ivancica Pavlicevic Family Practice Office
Information provided by:
University of Split
ClinicalTrials.gov Identifier:
NCT00631514
First received: February 27, 2008
Last updated: March 7, 2008
Last verified: February 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: acetaminophen
Drug: ibuprofen
Drug: piroxicam
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Relevance of the Interaction Between Antihypertensive and Antirheumatic Drugs in a Family Practice

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Split:

Primary Outcome Measures:
  • Arterial blood pressure [ Time Frame: 3 months (3 individual blocks of 1 month each) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Body weight,serum electrolytes, urinary electrolytes (Na, K) [ Time Frame: 3 months (3 periods of 1 month) ] [ Designated as safety issue: Yes ]

Enrollment: 88
Study Start Date: January 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   55 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631514

Locations
Croatia
Split University School of Medicine. Family Practice Department
Split, Croatia, 21000
Sponsors and Collaborators
University of Split
Dr Ivancica Pavlicevic Family Practice Office
Investigators
Study Director: Zvonko - Rumboldt, MD, PhD Split University School of Medicine
  More Information

Additional Information:
Split University School of Medicine  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ivancica Pavlicevic, Split University School of Medicine
ClinicalTrials.gov Identifier: NCT00631514     History of Changes
Other Study ID Numbers: 1-Pavlicevic
Study First Received: February 27, 2008
Last Updated: March 7, 2008
Health Authority: Croatia: National Ethics Committee; Zagreb, Croatia

Keywords provided by University of Split:
antihypertensive drugs
non-steroidal anti-inflammatory drugs
interaction
family practice
arterial blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Acetaminophen
Ibuprofen
Piroxicam
Antirheumatic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antihypertensive Agents
Antipyretics
Physiological Effects of Drugs
 Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Cardiovascular Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013