Hyperlipidemia Clinical Trial
— SPIRE-SIOfficial title:
A Phase 3, Double-blind, Double-dummy, Randomized, Placebo And Active Controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Dyslipidemia Who Are Intolerant To Statins
| Verified date | November 2017 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are statin intolerant.
| Status | Completed |
| Enrollment | 184 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Hyperlipidemia - Statin Intolerant - Fasting LDL-C > = 70 mg/dL Fasting TG < = 400 mg/dL Exclusion Criteria: - Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or procedure within 90 days - Severe or life-threatening adverse events with past use of statins - Poorly controlled hypertension |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Ecogene-21 | Chicoutimi | Quebec |
| Canada | Corunna Medical Research Centre | Corunna | Ontario |
| Canada | The Medical Arts Health Research Group | Kelowna | British Columbia |
| Canada | Omnispec clinical research inc. | Mirabel | Quebec |
| Canada | The Office of Dr. James Cha | Oshawa | Ontario |
| Canada | Kawartha Cardiology Clinical Trials | Peterborough | Ontario |
| Canada | Clinique des maladies lipidiques de Quebec | Quebec | |
| Canada | Diex Research Sherbrooke Inc. | Sherbrooke | Quebec |
| Canada | Devonshire Clinical Research Inc. | Woodstock | Ontario |
| United States | Bridgeport Hospital | Bridgeport | Connecticut |
| United States | PMG Research of Bristol | Bristol | Tennessee |
| United States | Dayton Heart Center | Dayton | Ohio |
| United States | Creekside Endocrine Associates, PC | Denver | Colorado |
| United States | NorthShore University HealthSystem - Evanston Hospital | Evanston | Illinois |
| United States | San Antonio Military Medical Center | Fort Sam Houston | Texas |
| United States | East-West Medical Research Institute | Honolulu | Hawaii |
| United States | Office of Michelle Zaniewski MD., PA. | Houston | Texas |
| United States | The University of Iowa - College of Public Health - Preventive Intervention Center | Iowa City | Iowa |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | PMG Research of Knoxville, LLC | Knoxville | Tennessee |
| United States | Watson Clinic Center for Research, Inc. (for Drug Shipment only) | Lakeland | Florida |
| United States | Utah Cardiology, P.C. | Layton | Utah |
| United States | Crescent City Clinical Research Center | Metairie | Louisiana |
| United States | Cardiovascular Research Center Of South Florida | Miami | Florida |
| United States | Allina Health System, dba Abbott Northwestern Hospital | Minneapolis | Minnesota |
| United States | Minneapolis Heart Institute Foundation | Minneapolis | Minnesota |
| United States | Health Care Centers of Illinois Mokena Medical Commons | Mokena | Illinois |
| United States | Advocate Medical Group Cardiology | Normal | Illinois |
| United States | Aspen Clinical Research LLC | Orem | Utah |
| United States | Advocate Medical Group Midwest Heart Specialists | Park Ridge | Illinois |
| United States | Clinical and Translational Research Center, Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania |
| United States | St. Johns Center for Clinical Research | Ponte Vedra | Florida |
| United States | Progressive Medical Research | Port Orange | Florida |
| United States | Prairie Education & Research Cooperative (Administrative) | Springfield | Illinois |
| United States | Prairie Heart Institute | Springfield | Illinois |
| United States | St. John's Hospital | Springfield | Illinois |
| United States | The Iowa Clinic, PC | West Des Moines | Iowa |
| United States | PMG Research of Wilmington, LLC | Wilmington | North Carolina |
| United States | Berks Cardiologists, Ltd. | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline, Week 12 | ||
| Secondary | Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24 | Baseline, Week 12, 24 | ||
| Secondary | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24 | Baseline, Week 12, 24 | ||
| Secondary | Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24 | Baseline, Week 12, 24 | ||
| Secondary | Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24 | Baseline, Week 12, 24 | ||
| Secondary | Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24 | Baseline, Week 12, 24 | ||
| Secondary | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 | Baseline, Week 24 | ||
| Secondary | Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24 | Baseline, Week 12, 24 | ||
| Secondary | Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24 | Baseline, Week 12, 24 | ||
| Secondary | Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24 | Baseline, Week 12, 24 | ||
| Secondary | Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24 | Baseline, Week 12, 24 | ||
| Secondary | Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline, Week 12 | ||
| Secondary | Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 | Baseline, Week 12 | ||
| Secondary | Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline, Week 12 | ||
| Secondary | Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | Baseline, Week 12 | ||
| Secondary | Absolute Change From Baseline in Fasting Triglycerides (TG) at Week 12 | Baseline, Week 12 | ||
| Secondary | Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | Baseline, Week 12 | ||
| Secondary | Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12 | Baseline, Week 12 | ||
| Secondary | Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 | Baseline, Week 12, 24 | ||
| Secondary | Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 | Baseline, Week 12, 24 | ||
| Secondary | Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 | Week 12, 24 | ||
| Secondary | Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 | Week 12, 24 | ||
| Secondary | Plasma PF-04950615 Concentrations at Weeks 12 and 24 | Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.4 micrograms per milliliter [mcg/mL]) to zero. Participants who received PF-04950615 150 mg were evaluable for this outcome measure. | Week 12 and 24 | |
| Secondary | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Baseline (Day 1) up to Week 30 | ||
| Secondary | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb) | Participants with at least one positive ADA titer greater than or equal to (>=) 6.23 or positive nAb titer >=4.32 were reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint. | Baseline up to Week 30 | |
| Secondary | Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively | Titer levels of participants who tested positive for ADA and nAb are reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint. | Week 4, 12, 24 and 30 (Follow-up) | |
| Secondary | Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Baseline (Day 1) up to Week 30 |
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