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

Arm | Intervention/treatment |
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No Intervention: 1
Hypertensive persons taking either lisinopril/hydrochlorothiazide fixed combination or amlodipine all the time.
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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
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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
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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 |
- Arterial blood pressure [ Time Frame: 3 months (3 individual blocks of 1 month each) ]
- Body weight,serum electrolytes, urinary electrolytes (Na, K) [ Time Frame: 3 months (3 periods of 1 month) ]

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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 |
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)

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
Croatia | |
Split University School of Medicine. Family Practice Department | |
Split, Croatia, 21000 |
Study Director: | Zvonko - Rumboldt, MD, PhD | Split University School of Medicine |
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 |
Other Study ID Numbers: |
1-Pavlicevic |
First Posted: | March 7, 2008 Key Record Dates |
Last Update Posted: | March 10, 2008 |
Last Verified: | February 2008 |
antihypertensive drugs non-steroidal anti-inflammatory drugs interaction family practice arterial blood pressure |
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 |