A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
Purpose
This is a multicenter, randomized, double-blind, factorial design Phase 2 study to evaluate the pharmacodynamics, safety and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484, inclisiran, and placebo in participants with hypertension and concomitant hypercholesterolemia.
Condition
- Hypercholesterolaemia
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Males or females aged 18 to 75 years. - Diagnosis of primary hypertension. - Treatment with either no, or up to 2 antihypertensive medications at a stable dose for at least 4 weeks preceding screening. - Systolic blood pressure ≥140 and <165 mmHg based on the mean of 3 sitting measurements based on office blood pressure monitoring. - Diagnosis of hypercholesterolemia including heterozygous familial hypercholesterolemia unable to reach LDL-C goals with a stable dose of statin treatment for at least 4 weeks prior to screening as per Investigator judgement, guidelines and local practice (if tolerated and not contraindicated) with or without bempedoic acid and with or without ezetimibe prescribed according to local guidance, at a stable dose for at least 4 weeks preceding Screening Visit 1. The following parameters must be confirmed at Screening Visit 2: - Fasting serum LDL-C ≥70 mg/dL and <190 mg/dL using Friedewald equation. - Fasting triglyceride <400 mg/dL.
Exclusion Criteria
- Symptomatic orthostatic hypotension. - Treatment with certain medications and/or unable to comply with prohibited medications requirements. Other protocol inclusion/exclusion criteria may apply
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental QCZ484 + Inclisiran |
QCZ484 + inclisiran, once on Day 1 |
|
|
Active Comparator QCZ484 |
QCZ484 + inclisiran placebo, once on Day 1 |
|
|
Active Comparator Inclisiran |
Inclisiran + QCZ484 placebo, once on Day 1 |
|
|
Placebo Comparator Placebo |
QCZ484 placebo + inclisiran placebo, once on Day 1 |
|
Recruiting Locations
The Center for Clinical Trials
Saraland, Alabama 36571
Saraland, Alabama 36571
Clinical Trials Research
Lincoln, California 95648
Lincoln, California 95648
Downtown L A Research Center Inc
Los Angeles, California 90017
Los Angeles, California 90017
Valley Clinical Trials
Northridge, California 91325
Northridge, California 91325
Flourish Medical Clinical Trials
Boca Raton, Florida 33434
Boca Raton, Florida 33434
ALL Medical Research LLC
Cooper City, Florida 33024
Cooper City, Florida 33024
Universal Axon Clinical Research
Doral, Florida 33166
Doral, Florida 33166
East Coast Institute for Research
Jacksonville, Florida 32216
Jacksonville, Florida 32216
Entrust Clinical Research
Miami, Florida 33176
Miami, Florida 33176
Inpatient Research Clinical LLC
Miami Lakes, Florida 33014
Miami Lakes, Florida 33014
Inpatient Research Clinical LLC
Miami Lakes, Florida 33014
Miami Lakes, Florida 33014
American Research Centers of FL
Pembroke Pines, Florida 33027
Pembroke Pines, Florida 33027
East Coast Inst for Research LLC
Saint Augustine, Florida 32086
Saint Augustine, Florida 32086
Great Lakes Clinical Trials
Chicago, Illinois 60640
Chicago, Illinois 60640
AMR Chicago
Niles, Illinois 60714
Niles, Illinois 60714
Alliance for Multispecialty Research
Wichita, Kansas 67207
Wichita, Kansas 67207
Monroe Research Llc
West Monroe, Louisiana 71291
West Monroe, Louisiana 71291
Anderson Medical Research
Ft. Washington, Maryland 20744
Ft. Washington, Maryland 20744
Monroe Biomedical Research
Monroe, North Carolina 28112
Monroe, North Carolina 28112
Walker Family Care
Little River, South Carolina 29566
Little River, South Carolina 29566
Manassas Clinical Research Center
Manassas, Virginia 20110
Manassas, Virginia 20110
Dominion Medical Associates
Richmond, Virginia 23219
Richmond, Virginia 23219
More Details
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
Detailed Description
The study will last up to 12 months and has three periods: - Eligibility will be assessed during the screening period including 2 screening visits. Some eligibility criteria will be confirmed at the Baseline/Randomization visit. - Eligible participants will be randomized to receive a combination of QCZ484 and inclisiran, QCZ484, inclisiran or placebo once on Day 1 at the Baseline/Randomization visit. - Afterwards, participants will enter the safety follow-up period. Eligible participants who complete the treatment period have the option to participate in an open-label extension study instead of entering the safety follow-up period.