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

Tracking Information

First Received Date ^ICMJE

February 27, 2008

Last Updated Date

March 7, 2008

Start Date ^ICMJE

January 2005

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00631514 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Relevance of the Interaction Between Antihypertensive and Antirheumatic Drugs in a Family Practice

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.

Detailed Description

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: acetaminophen
Drug: ibuprofen
Drug: piroxicam

Study Arms / Comparison Groups

No Intervention: Hypertensive persons taking either lisinopril/hydrochlorothiazide fixed combination or amlodipine all the time.
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
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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2006

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

55 Years to 78 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Croatia

Administrative Information

NCT ID ^ICMJE

NCT00631514

Responsible Party

Ivancica Pavlicevic, Split University School of Medicine

Study ID Numbers ^ICMJE

1-Pavlicevic

Study Sponsor ^ICMJE

University of Split

Collaborators ^ICMJE

Dr Ivancica Pavlicevic Family Practice Office

Investigators ^ICMJE

Study Director:

Zvonko - Rumboldt, MD, PhD

Split University School of Medicine

Information Provided By

University of Split

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP