Safety and Efficacy of Lumiracoxib in Patients With Osteoarthritis and With Controlled Hypertension - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00267176

Purpose

This study will investigate the effect on ambulatory blood pressure of lumiracoxib 100 mg once daily versus ibuprofen 600 mg three times a day in osteoarthritis patients with controlled hypertension.

Condition	Intervention	Phase
Osteoarthritis, Controlled Hypertension	Drug: lumiracoxib	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A 4-Week, Multicentre, Randomized, Double-Blind, Double-Dummy, Parallel Group Ambulatory Blood Pressure Monitoring Study to Investigate Whether Treatment With Lumiracoxib 100 mg Once Daily Results in an Improved 24-Hour Blood Pressure Profile Compared to Ibuprofen 600 mg Three Times a Day in Osteoarthritis Patients With Controlled Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Osteoarthritis

Drug Information available for: Ibuprofen Lumiracoxib

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Assessment of the 24-hour systolic BP profile of lumiracoxib 100 mg o.d. in comparison to ibuprofen 600 mg t.i.d. after 4 weeks of treatment.

Secondary Outcome Measures:

Assessment of the effect of lumiracoxib 100 mg o.d. on diastolic BP derived from ABPM after 4 weeks of treatment in comparison to ibuprofen 600 mg t.i.d.
Assessment of the effect of lumiracoxib 100 mg o.d. on daytime and nighttime BP (systolic and diastolic) derived from ABPM after 4 weeks of treatment in comparison to ibuprofen 600 mg t.i.d.
Assessment of the effect of lumiracoxib 100 mg o.d. on the incidence of significant increases in ABP in comparison to ibuprofen 600 mg t.i.d.
Exploratory analysis of the effect of lumiracoxib 100 mg o.d. on the incidence of uncontrolled hypertension in comparison to ibuprofen 600 mg t.i.d.
Exploratory analysis of the effect of lumiracoxib 100 mg o.d. on the ABPM profile between 0 and 4 hours after morning dose in comparison to ibuprofen 600 mg t.i.d.

Estimated Enrollment:	1020
Study Start Date:	November 2005

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Osteoarthritis of the hand, hip, knee or spine
High blood pressure (<140/ 90 mmHg) which is controlled by antihypertensive medication(s).

Exclusion criteria

• Evidence or history of any cardiac and cerebral thrombotic/ ischemic diseases and/ or events

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267176

Locations

United States, Illinois
Southern Illinois Clinical Research
O'Fallon, Illinois, United States, 62269
Germany
Novartis
Nuernberg, Germany

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Bradkey Sakran, MD

Southern Illinois Clinical Research

More Information

Additional Information:

Osteoarthritis and High Blood Pressure Study This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00267176 History of Changes
Other Study ID Numbers:	CCOX189A2428
Study First Received:	December 16, 2005
Last Updated:	December 13, 2007
Health Authority:	Austria: Federal Ministry for Health and Women; Belgium: Directorate general for the protection of Public health: Medicines; Brazil: National Health Surveillance Agency; Finland: Finnish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Keywords provided by Novartis:

Osteoarthritis,
hypertension,
lumiracoxib,
ibuprofen,
24-hour blood pressure profile

Additional relevant MeSH terms:

Hypertension
Osteoarthritis
Vascular Diseases
Cardiovascular Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lumiracoxib
Diclofenac
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012