NCT00631514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
Last Updated

March 10, 2008

Status Verified

February 1, 2008

Enrollment Period

1.7 years

First QC Date

February 27, 2008

Last Update Submit

March 7, 2008

Conditions

Hypertension

Keywords

antihypertensive drugsnon-steroidal anti-inflammatory drugsinteractionfamily practicearterial blood pressure

Outcome Measures

Primary Outcomes (1)

  • Arterial blood pressure

    3 months (3 individual blocks of 1 month each)

Secondary Outcomes (1)

  • Body weight,serum electrolytes, urinary electrolytes (Na, K)

    3 months (3 periods of 1 month)

Study Arms (3)

1

NO INTERVENTION

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

2

EXPERIMENTAL

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: acetaminophenDrug: ibuprofenDrug: piroxicam

3

EXPERIMENTAL

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: acetaminophenDrug: ibuprofenDrug: piroxicam

Interventions

acetaminophenDRUG

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

Also known as: paracetamol
23
ibuprofenDRUG

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

23
piroxicamDRUG

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

23

Eligibility Criteria

Age55 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Normotensive persons or untreated hypertensives
  • Individuals outside the age limits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Split University School of Medicine. Family Practice Department

Split, 21000, Croatia

Location

Related Publications (2)

  • 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.

    PMID: 16485829BACKGROUND

  • 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.

    PMID: 18953082DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

AcetaminophenIbuprofenPiroxicam

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic AcidsThiazinesSulfur CompoundsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Zvonko - Rumboldt, MD, PhD

    Split University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2008

First Posted

March 7, 2008

Study Start

January 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

March 10, 2008

Record last verified: 2008-02

Locations

CR(1)