Clinical Trials Logo
  1. Home
  2. Dyslipidemia
  3. NCT00125125
  4. Details
NCT00125125 Clinical Trial

Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

Dyslipidemia Clinical Trial

Official title:
Efficacy and Tolerability of Fluvastatin in Adults With Dislipidemia With History of Muscle Problems Due to Other Previous Statin Intake

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00125125
Other study ID # CXUO320B2406
Secondary ID
Status Completed
Phase Phase 4
First received July 28, 2005
Last updated May 15, 2017
Start date May 2005
Est. completion date December 2005

Study information
Verified date May 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to find a good therapy for patients who need to be treated for high cholesterol and who have difficulty tolerating other statins (such as pravastatin, simvastatin, lovastatin, atorvastatin, rosuvastatin) due to muscle pain.

Recruitment information / eligibility
Status Completed
Enrollment 218
Est. completion date December 2005
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Dyslipidemia

- History of Myalgia

Exclusion Criteria:

- Previous treatment with fluvastatin

- Age < 18 years

Other protocol-defined inclusion and exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fluvastatin

Locations
Country Name City State
United States Novartis East Hanover New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in low density lipoprotein cholesterol after 12 weeks
Secondary Tolerability as assessed by muscle-related adverse events, and muscle-related adverse events leading to discontinuation
Secondary Change from baseline in total cholesterol, triglycerides, high density lipoprotein cholesterol, and lipoprotein subtypes after 12 weeks
Secondary Number of patients who reach target LDL after 12 weeks
Secondary Change from baseline in marker of inflammation after 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT00001154 - Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
Not yet recruiting NCT06405880 - Pharmacist Case Finding and Intervention for Vascular Prevention Trial N/A
Recruiting NCT02837367 - Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People N/A
Active, not recruiting NCT02600338 - Meta-analyses of the Effect of Legumes on Blood Pressure N/A
Active, not recruiting NCT02223793 - Vascular Lifestyle-Intervention and Screening in Pharmacy N/A
Completed NCT02163044 - The Hellenic Postprandial Lipemia Study (HPLS)
Recruiting NCT01972113 - Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study) N/A
Recruiting NCT01705873 - Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen N/A
Completed NCT01764295 - Clinical Study for Patients With Hypertension Associated With Dyslipidemia Phase 3
Terminated NCT01414166 - Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108) Phase 3
Completed NCT01531062 - Effect of Nigella Sativa on Lipid Profiles in Elderly Phase 2
Completed NCT01990391 - Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities N/A
Recruiting NCT01670968 - HIV Reverse Cholesterol Transport Study
Completed NCT00977288 - A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029) Phase 2
Completed NCT01285544 - The Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia Phase 4
Completed NCT00768274 - Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol Phase 1/Phase 2
Withdrawn NCT00664287 - Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082) Phase 3
Completed NCT00300430 - Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia. Phase 3
Completed NCT01483235 - Reduced Cardiac Rehabilitation Program N/A
Terminated NCT00816829 - Effect of Fenofibrate on Sleep Apnea Syndrome Phase 2

External Links