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

April 16, 2008
June 16, 2011
March 2008
August 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00662610 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure
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

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Osteoarthritis
  • Hypertension
  • Drug: naproxcinod 375 mg -750 mg -1125 mg bid
    naproxcinod 375 mg -750 mg -1125 mg bid
  • Drug: naproxen 250 mg - 500mg -750 mg bid
    naproxen 250 mg - 500mg -750 mg bid
  • Experimental: naproxcinod 375 mg - 750 mg -1125 mg bid
    dose escalating
    Intervention: Drug: naproxcinod 375 mg -750 mg -1125 mg bid
  • Active Comparator: naproxen 250 mg -500 mg -750 mg bid
    dose escalating
    Intervention: Drug: naproxen 250 mg - 500mg -750 mg bid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
November 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00662610
HCT3012-X-111
Yes
NicOx, NicOx.
NicOx
Not Provided
Not Provided
NicOx
June 2011

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