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

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ClinicalTrials.gov Identifier: NCT00631514
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : March 10, 2008
Sponsor:
Collaborator:
Dr Ivancica Pavlicevic Family Practice Office
Information provided by:
University Hospital of Split

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: acetaminophen Drug: ibuprofen Drug: piroxicam Phase 4

Detailed Description:
To compare prospectively the effects of piroxicam, ibuprofen and acetaminophen on blood pressure control in hypertensive patients with osteoarthritis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Relevance of the Interaction Between Antihypertensive and Antirheumatic Drugs in a Family Practice
Study Start Date : January 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

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Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. Arterial blood pressure [ Time Frame: 3 months (3 individual blocks of 1 month each) ]

Secondary Outcome Measures :
  1. Body weight,serum electrolytes, urinary electrolytes (Na, K) [ Time Frame: 3 months (3 periods of 1 month) ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631514


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

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

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Responsible Party: Ivancica Pavlicevic, Split University School of Medicine
ClinicalTrials.gov Identifier: NCT00631514    
Other Study ID Numbers: 1-Pavlicevic
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: March 10, 2008
Last Verified: February 2008
Keywords provided by University Hospital of Split:
antihypertensive drugs
non-steroidal anti-inflammatory drugs
interaction
family practice
arterial blood pressure
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Acetaminophen
Ibuprofen
Piroxicam
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action