Safety and Efficacy of Lumiracoxib in Patients With Osteoarthritis and With Controlled Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00267176
First received: December 16, 2005
Last updated: May 18, 2012
Last verified: May 2012
  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 4

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:


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
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Pharmaceuticals
Investigators
Principal Investigator: Bradkey Sakran, MD Southern Illinois Clinical Research
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00267176     History of Changes
Other Study ID Numbers: CCOX189A2428
Study First Received: December 16, 2005
Last Updated: May 18, 2012
Health Authority: Austria: Federal Ministry for Health and Women
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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
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
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014