A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure - Full Text View

Sponsor:	NicOx
Information provided by:	NicOx
ClinicalTrials.gov Identifier:	NCT00662610

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, naproxen	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
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:

MedlinePlus related topics: High Blood Pressure Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium AZD 3582

U.S. FDA Resources

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
naproxcinod: Active Comparator	Drug: naproxcinod, naproxen
naproxen: Active Comparator	Drug: naproxcinod, naproxen

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662610

Show 30 Study Locations

Sponsors and Collaborators

NicOx

More Information

Additional Information:

NicOx website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	NicOx. ( NicOx )
Study ID Numbers:	HCT3012-X-111
Study First Received:	April 16, 2008
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00662610 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Physiological Effects of Drugs
Gout Suppressants
Nitric Oxide Donors
Musculoskeletal Diseases
Sensory System Agents
Arthritis
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Diseases
Analgesics
Naproxen

Joint Diseases
Cyclooxygenase Inhibitors
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Rheumatic Diseases
Pharmacologic Actions
Analgesics, Non-Narcotic
Naproxen-n-butyl nitrate
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010