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

NCT ID: NCT00631514

Last Updated: 2008-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-09-30

Brief Summary

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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

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

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Hypertensive persons taking either lisinopril/hydrochlorothiazide fixed combination or amlodipine all the time.

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

acetaminophen

Intervention Type DRUG

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

ibuprofen

Intervention Type DRUG

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

piroxicam

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

acetaminophen

Intervention Type DRUG

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

ibuprofen

Intervention Type DRUG

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

piroxicam

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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paracetamol

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Ivancica Pavlicevic Family Practice Office

UNKNOWN

Sponsor Role collaborator

University Hospital of Split

OTHER

Sponsor Role lead

Responsible Party

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Split University School of Medicine

Principal Investigators

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Zvonko - Rumboldt, MD, PhD

Role: STUDY_DIRECTOR

Split University School of Medicine

Locations

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Split University School of Medicine. Family Practice Department

Split, , Croatia

Site Status

Countries

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Croatia

References

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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.

Reference Type BACKGROUND
PMID: 16485829 (View on PubMed)

Pavlicevic 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.

Reference Type DERIVED
PMID: 18953082 (View on PubMed)

Other Identifiers

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1-Pavlicevic

Identifier Type: -

Identifier Source: org_study_id

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