HypertensionPhase 2NCT02791958
Pharmacodynamic Equivalence of Ramipril 10 mg and Atorvastatin 40 mg Administered as a Cardiovascular (CV) Polypill Acetylsalicylic Acid-Atorvastatin-Ramipril (AAR) as Compared to Monotherapy
A Phase 2 study testing Cardiovascular Fixed Dose Combination Pill AAR, Atorvastatin 40 mg and Ramipril 10 mg in people with Hypertension, run by Ferrer Internacional S.A. at 36 sites in United States.
Trial summary
This study is to compare the pharmacodynamics of a Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg) and the respective reference products, atorvastatin (Lipitor®) 40 mg and ramipril (Altace®) 10 mg. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Cardiovascular Fixed Dose Combination Pill AAR, Atorvastatin 40 mg and Ramipril 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 36 sitesUnited States
- Study dates
- Mar 2016to Oct 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥18 and <75 years.
- Patients with Stage 1 (SBP/DBP: 140-159/90-99 mmHg) or Stage 2 (SBP/DBP: ≥160/≥100 mmHg) hypertension, either untreated or after a wash out period.
- Patients with an LDL cholesterol level of ≥100 mg/dL and, either untreated or after the wash out period.
- Patients untreated with BP lowering and / or lipid lowering medication
- Patients treated with BP lowering and / or lipid lowering medication can be included if the medication can be safely withdrawn as per physician's judgment.
- Provide written informed consent.
Who cannot join
- Patients with a BMI of > 35
- SBP < 140 mmHg and DBP < 90 mmHg
- Severe hypertension defined as SBP > 180 mmHg and Diastolic Blood Pressure (DBP) > 110 mmHg
- LDL cholesterol level of <100 mg/dL, either untreated or after the wash out period.
- Serum triglyceride concentration ≥400 mg/dL, either untreated or after the wash out period.
- Patients with a medical condition requiring the chronic pharmacological treatments listed below:
Show all 43Show fewer
- Cytochrome P450 3A4 (CYP3A4) inhibitors (eg itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone).
- Non-steroidal anti-inflammatory drugs (NSAIDs).
- K-sparing diuretics.
- Lithium.
- Amiodarone and verapamil.
- Oral anticoagulants (eg, warfarin).
- Steroids.
- Digoxin.
- Gemfibrozil.
- Niacin.
- Potassium supplements.
- Cyclosporine.
- Danazol.
- Rifampicin.
- Evidence of any known clinically significant chronic disease
- Patients with renal impairment with Creatinine Clearance (CrCl) < 40 mL/ min/ 1.73 m2
- Creatine phosphokinase (CPK) ≥5 x the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x ULN.
- Total bilirubin ≥1.5 x ULN
- Medical history or evidence of drug or alcohol abuse.
- Medical history of gastrointestinal bleeding or gastroduodenal ulcer.
- Presence of secondary dyslipidemia.
- For patients on antihypertensive and/ or cholesterol lowering medication impossibility to withdraw it safely as per physician's judgment
- Previous coronary artery bypass graft (CABG).
- Previous percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent.
- Presence of severe congestive heart failure (New York Heart Classification (NYHC) III IV).
- Prior history of stroke, Transient Ischemic Attack (TIA), Myocardial Infarction (MI), and cardiomyopathy with systolic dysfunction (prior documented Left Ventricular Ejection Fraction (LVEF) < 40%)
- Aspirin induced asthma
- Previous intolerance and/or hypersensitivity to ACE inhibitors, statins and/or salicylates.
- Presence of unstable angina.
- Lab values other than specified out of the central laboratory normal range considered clinically significant.
- Patients and their partners not using effective contraception methods (i.e. intra uterine device (IUD) and condom or diaphragm with spermicide and condom) during the study and for at least one month thereafter, oral contraceptives are allowed.
- Pregnant, lactating, breastfeeding, or intends to become pregnant during the course of the study (females only). All women must have a negative urine pregnancy test at the Screening Visit, be surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or have a postmenopausal status (no menses) for at least one year.
- Presence of mental illness limiting the capacity for self-care.
- Presence of major systemic illnesses: renal disease, liver disease, neurological or psychiatric disease.
- Participation, in the 30 days preceding enrolment into the study, in any other clinical study in which investigational or marketed drugs were employed.
- Any other medical condition that in the investigators opinion may interfere with the study procedures and/or evaluations.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Central Alabama Research
Birmingham, Alabama, 35209
Meridien Research
Bradenton, Florida, 34208
PAB Clinical Research
Brandon, Florida, 33511
Punzi Medical Center
Carrollton, Texas, 75006
Cedar Crosse Research Center
Chicago, Illinois, 60607
Clinical Research of South Florida
Coral Gables, Florida, 33134
Clinical Therapeutics Corporation
Coral Gables, Florida, 33134
Moonshine Research Center, Inc
Doral, Florida, 33166
Riverside Clinical Research
Edgewater, Florida, 32132
Nova Clinical Research Center inc
Hialeah, Florida, 33013
Dr. John C. Gutleber Weight Loss, Beauty, and Family Practice
Homestead, Florida, 33030
Cullen Research, LLC
Houston, Texas, 77051
Research Trials Worldwide LLC
Humble, Texas, 77338
Westside Center for Clinical Research
Jacksonville, Florida, 32205
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Health Awareness, Inc.
Jupitor, Florida, 33458
The Chappel Group Research
Kissimmee, Florida, 34744
Einstein Clinical Research
Lancaster, South Carolina, 29720
Sunrise Medical Center
Lauderdale Lakes, Florida, 33319
National Research Institute
Los Angeles, California, 90057
Louisville Metabolic and Atherosclerosis Research
Louisville, Kentucky, 40213
Clinical Trials of America LA, LLC
Monroe, Louisiana, 71201
Central Texas Health Research
New Braunfels, Texas, 78130
DelRicht Research
New Orleans, Louisiana, 70124
Clinical Research Source
Perrysburg, Ohio, 43551
Deleon Research, PLLC
Plano, Texas, 75093
Progressive Medical Research
Port Orange, Florida, 32127
Clinical Trials Research
Sacramento, California, 95821
Physician PrimeCare Research Institute, PLLC dba H
San Antonio, Texas, 78228
Diagnostics Research Group
San Antonio, Texas, 78229
Sylvana Research
San Antonio, Texas, 78229
Chysalis Clinical Research
St. George, Utah, 84790
Meridien Research
St. Petersburg, Florida, 33709
Clinical Trials Investigators, Inc
Tustin, California, 92780
Bay State Clinical Trials, Inc
Watertown, Massachusetts, 02472
Infoshpere Clinical Research, Inc
West Hills, California, 91307
About this study
Official title: Pharmacodynamic Equivalence Study of Ramipril 10 mg and Atorvastatin 40 mg Administered as a Cardiovascular Fixed Dose Combination Pill AAR as Compared to Monotherapy With the Reference Products Altace® 10 mg and Lipitor® 40 mg
This study is to compare the pharmacodynamics of a Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg) and the respective reference products, atorvastatin (Lipitor®) 40 mg and ramipril (Altace®) 10 mg.
- Conditions
- Hypertension
- Being tested
- Cardiovascular Fixed Dose Combination Pill AAR, Atorvastatin 40 mg, Ramipril 10 mg
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Fixed Dose Combination Pill AARDrug
A once daily oral dose of the Cardiovascular Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg) for 4 weeks.
Atorvastatin 40 mgDrug
A once daily oral dose of atorvastatin 40 mg (Lipitor®) for 4 weeks
Ramipril 10 mgDrug
A once daily oral dose of ramipril 10 mg (Altace®) for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| CV Fixed Dose Combination Pill AAR | Experimental | Cardiovascular Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg). Receives: Drug: Cardiovascular Fixed Dose Combination Pill AAR |
| Atorvastatin | Active comparator | Atorvastatin 40 mg (Lipitor®). Receives: Drug: Atorvastatin 40 mg |
| Ramipril | Active comparator | Ramipril 10 mg (Altace®). Receives: Drug: Ramipril 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the adjusted mean 24-h systolic blood pressure results using ABPM between the baseline (week 0) and the final visit (week 8).
Measured: Measures at baseline visit (week 0) and final visit (week 8).
Difference in LDL cholesterol levels between the baseline (week 4) and the final visit (week 8).
Measured: Measures at baseline visit (week 4) and final visit (week 8).
Secondary outcomes (8)
Difference in the adjusted mean 24-h diastolic blood pressure results (using ABPM) between the basal and the final visits.
Measured: Measures at baseline visit (week 0) and final visit (week 8).
Difference in the adjusted mean 24-h mean arterial pressure results (using ABPM) between the basal and the final visits.
Measured: Measures at baseline visit (week 0) and final visit (week 8).
Difference in the adjusted mean 24-h heart rate results (using ABPM) between the basal and the final visits.
Measured: Measures at baseline visit (week 0) and final visit (week 8).
Difference in Very Low-Density Lipoprotein (VLDL) cholesterol levels between the basal and the final visits.
Measured: Measures at baseline visit (week 0) and final visit (week 8).
Difference in HDL cholesterol levels between the basal and the final visits.
Measured: Measures at baseline visit (week 0) and final visit (week 8).
Difference in total cholesterol levels between the basal and the final visits.
Measured: Measures at baseline visit (week 0) and final visit (week 8).
Difference in triglyceride levels between the basal and the final visits.
Measured: Measures at baseline visit (week 0) and final visit (week 8).
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
AEs, clinical laboratory parameters (hematology, clinical chemistry, and urinalysis), vital signs, electrocardiogram (ECG), and physical examination.
The total number of patients with at least one AE and the number of AEs will be included in listings and tabulations. AEs will be coded using MedDRA, classified by system organ class (SOC) and preferred term and tabulated by intensity and causal relationship for each treatment.
Measured: Through study completion, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ferrer Internacional S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Surowitz, Principal investigator, Health Awareness, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791958
- Sponsor's protocol ID
- FCD-PP-1501
- Status last verified
- Apr 2017
- First submitted
- 15 Feb 2016
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Equivalence Study of Ramipril 10 mg and Atorvastatin 40 mg Administered as a Cardiovascular Fixed Dose Combination Pill AAR as Compared to Monotherapy With the Reference Products Altace® 10 mg and Lipitor® 40 mg
- ClinicalTrials.gov ID
- NCT02791958
- Acronym / sponsor ID
- FCD-PP-1501
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- Ferrer Internacional S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to compare the pharmacodynamics of a Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg) and the respective reference products, atorvastatin (Lipitor®) 40 mg and ramipril (Altace®) 10 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CV Fixed Dose Combination Pill AAR | Experimental | Drug: Cardiovascular Fixed Dose Combination Pill AARCardiovascular Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg). |
| Atorvastatin | Active comparator | Drug: Atorvastatin 40 mgAtorvastatin 40 mg (Lipitor®). |
| Ramipril | Active comparator | Drug: Ramipril 10 mgRamipril 10 mg (Altace®). |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged ≥18 and <75 years.
- Patients with Stage 1 (SBP/DBP: 140-159/90-99 mmHg) or Stage 2 (SBP/DBP: ≥160/≥100 mmHg) hypertension, either untreated or after a wash out period.
- Patients with an LDL cholesterol level of ≥100 mg/dL and, either untreated or after the wash out period.
- Patients untreated with BP lowering and / or lipid lowering medication
- Patients treated with BP lowering and / or lipid lowering medication can be included if the medication can be safely withdrawn as per physician's judgment.
Key exclusion criteria (43 listed)
- Patients with a BMI of > 35
- SBP < 140 mmHg and DBP < 90 mmHg
- Severe hypertension defined as SBP > 180 mmHg and Diastolic Blood Pressure (DBP) > 110 mmHg
- LDL cholesterol level of <100 mg/dL, either untreated or after the wash out period.
- Serum triglyceride concentration ≥400 mg/dL, either untreated or after the wash out period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular Fixed Dose Combination Pill AARA once daily oral dose of the Cardiovascular Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg) for 4 weeks. | Drug | CV Fixed Dose Combination Pill AAR |
| Atorvastatin 40 mgA once daily oral dose of atorvastatin 40 mg (Lipitor®) for 4 weeks | Drug | Atorvastatin |
| Ramipril 10 mgA once daily oral dose of ramipril 10 mg (Altace®) for 4 weeks | Drug | Ramipril |
Primary outcome
Difference in the adjusted mean 24-h systolic blood pressure results using ABPM between the baseline (week 0) and the final visit (week 8).
Time frame: Measures at baseline visit (week 0) and final visit (week 8).
Difference in LDL cholesterol levels between the baseline (week 4) and the final visit (week 8).
Time frame: Measures at baseline visit (week 4) and final visit (week 8).
8 secondary outcomes
Difference in the adjusted mean 24-h diastolic blood pressure results (using ABPM) between the basal and the final visits.
Time frame: Measures at baseline visit (week 0) and final visit (week 8).
Difference in the adjusted mean 24-h mean arterial pressure results (using ABPM) between the basal and the final visits.
Time frame: Measures at baseline visit (week 0) and final visit (week 8).
Difference in the adjusted mean 24-h heart rate results (using ABPM) between the basal and the final visits.
Time frame: Measures at baseline visit (week 0) and final visit (week 8).
Difference in Very Low-Density Lipoprotein (VLDL) cholesterol levels between the basal and the final visits.
Time frame: Measures at baseline visit (week 0) and final visit (week 8).
Difference in HDL cholesterol levels between the basal and the final visits.
Time frame: Measures at baseline visit (week 0) and final visit (week 8).
Difference in total cholesterol levels between the basal and the final visits.
Time frame: Measures at baseline visit (week 0) and final visit (week 8).
Difference in triglyceride levels between the basal and the final visits.
Time frame: Measures at baseline visit (week 0) and final visit (week 8).
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Through study completion, an average of 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Surowitz principal investigator
Health Awareness, Inc
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cardiovascular Fixed Dose Combination Pill AAR, Atorvastatin 40 mg and Ramipril 10 mg in people with Hypertension, run by Ferrer Internacional S.A. at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the adjusted mean 24-h systolic blood pressure results using ABPM between the baseline (week 0) and the final visit (week 8). (time frame: Measures at baseline visit (week 0) and final visit (week 8).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.