A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure (HCT3012-X-111)

This study has been completed.
Sponsor:
Information provided by:
NicOx
ClinicalTrials.gov Identifier:
NCT00662610
First received: April 16, 2008
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

To assess the effect of naproxcinod vs. naproxen on arterial blood pressure patients with osteoarthritis and controlled essential hypertension


Condition Intervention Phase
Osteoarthritis
Hypertension
Drug: naproxcinod 375 mg -750 mg -1125 mg bid
Drug: naproxen 250 mg - 500mg -750 mg bid
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 12-Week, Phase 1, Multicenter, Double-Blind, Randomized, Dose Ranging, Forced Titration, Naproxen-Controlled, Parallel-Group, Pharmacodynamic Study, to Assess the Effects Different Doses of Naproxcinod and Naproxen on Arterial Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Osteoarthritis Patients With Controlled Essential Hypertension

Resource links provided by NLM:


Further study details as provided by NicOx:

Primary Outcome Measures:
  • To characterize the 24-hour arterial blood pressure profile of different doses of naproxcinod, as measured by ABPM after each treatment period, compared to different doses of naproxen after three 3-week forced titration. [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the general safety and tolerability as well as the PK/PD profile of different doses of naproxcinod compared to different doses of naproxen. [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: March 2008
Study Completion Date: November 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: naproxcinod 375 mg - 750 mg -1125 mg bid
dose escalating
Drug: naproxcinod 375 mg -750 mg -1125 mg bid
naproxcinod 375 mg -750 mg -1125 mg bid
Active Comparator: naproxen 250 mg -500 mg -750 mg bid
dose escalating
Drug: naproxen 250 mg - 500mg -750 mg bid
naproxen 250 mg - 500mg -750 mg bid

Detailed Description:

This is a 12-week, randomized, double-blind, multicenter study comparing the effect of naproxcinod and naproxen on 24 hour arterial blood pressure profile. Patients will be randomly allocated to different naproxcinod or naproxen doses in a 1:1 ratio.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men/Women, 40 or older, diagnosed with hip or knee Osteoarthritis.
  • Hypertensive patient with treated and controlled essential hypertension.
  • Must receive at least one antihypertensive treatment from the following drug classes: Diuretic, Angiotensin-Converting Enzyme (ACE) inhibitor, Angiotensin Receptor Blocker (ARB) or Beta-Blocker (BB).
  • Must be current chronic user of NSAIDS or acetaminophen.
  • Must discontinue all analgesic therapy at Screening.

Exclusion Criteria:

  • More than two different classes of antihypertensive drugs.
  • Uncontrolled diabetes.
  • Hepatic or renal impairment.
  • A history of alcohol/drug abuse.
  • Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding.
  • History of congestive heart failure.
  • Clinically relevant abnormal ECG.
  • Current or expected use of anticoagulants.
  • Current or history of any medical disease that could interfere with the study objectives or put the patient's safety at risk.
  • Participation within 30 days prior to pre-screening in another investigational study.
  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: NCT00662610

  Show 29 Study Locations
Sponsors and Collaborators
NicOx
  More Information

No publications provided

Responsible Party: NicOx, NicOx.
ClinicalTrials.gov Identifier: NCT00662610     History of Changes
Other Study ID Numbers: HCT3012-X-111
Study First Received: April 16, 2008
Last Updated: June 16, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Osteoarthritis
Vascular Diseases
Cardiovascular Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Naproxen-n-butyl nitrate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Nitric Oxide Donors
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 31, 2014