- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01004705
A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol
31. juli 2012 opdateret af: Ferrer Internacional S.A.
Cardiovascular Fixed Dose Combination Pill: A Pharmacodynamic Study of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril in Subjects With Elevated LDL Cholesterol
This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of simvastatin given alone.
Approximately 76 subjects will be screened, 60 randomized in order about 52 subjects to finish the study.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
36
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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New York
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New York, New York, Forenede Stater, NY 10029-6574
- Mount Sinai Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or female subjects ≥18 years of age
- Previously untreated LDL cholesterol ≥100 mg/dL and ≤180 mg/dL.
- Provide written informed consent.
Exclusion Criteria:
- Subjects with a medical condition requiring chronic pharmacological treatment
- On direct questioning and physical examination have evidence of any clinically significant chronic disease, including known or suspected human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.
- On direct questioning and physical examination have a medical history or evidence of abuse of drugs.
- Medical history of gastrointestinal bleeding or gastric or duodenal ulcer.
- Systolic pressure ≥140 mmHg or diastolic pressure >89 mmHg requiring hypotensive medication.
- Presence of secondary dyslipidemia.
- Previous use of cholesterol lowering medication.
- 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).
- Presence of untreated or uncontrolled thyroid disease.
- Past or current medical history of asthma or aspirin induced asthma
- Previous hypersensitivity to ACE inhibitors (eg angioedema or cough).
- Previous hypersensitivity to ARBs.
- History of unstable angina.
- Serum creatinine >2 mg/dL.
- Creatine phosphokinase (CPK) ≥5 x the upper limit of normal (ULN).
- Hemoglobin ≤12 g/dL (120 g/L) for male subjects or ≤10 g/dL (100 g/L) for female subjects.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN.
- Total bilirubin ≥1.5 x ULN.
- Serum triglyceride concentration ≥400 mg/dL.
- Subjects not using effective contraception methods (intra uterine device [IUD] and condom or diaphragm with spermicide and condom) during the study and for at least one month thereafter.
- 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.
- Contraindications to or known or suspected hypersensitivity to aspirin, simvastatin or ramipril or their excipients.
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Fixed Dose Combination Pill
Once daily oral dose of combination of acetylsalicylic acid, simvastatin, and ramipril (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 or 10 mg ramipril)
|
A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 12 weeks.
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Aktiv komparator: Simvastatin
Once daily oral dose of Simvastatin 40 mg
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A once daily oral dose of simvastatin for 12 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The Difference in LDL Cholesterol Levels Between the Basal and the Final Visit of Each Treatment Period.
Tidsramme: Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2
|
Change from baseline in LDL cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.
|
Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The Difference in Mean Total Cholesterol Between the Basal and the Final Visit of Each Treatment Period.
Tidsramme: Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2
|
Change from baseline in mean total cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.
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Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2009
Primær færdiggørelse (Faktiske)
1. marts 2011
Studieafslutning (Faktiske)
1. marts 2011
Datoer for studieregistrering
Først indsendt
23. oktober 2009
Først indsendt, der opfyldte QC-kriterier
29. oktober 2009
Først opslået (Skøn)
30. oktober 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
31. august 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. juli 2012
Sidst verificeret
1. juli 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antihypertensive midler
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Blodpladeaggregationshæmmere
- Cyclooxygenase-hæmmere
- Antipyretika
- Antimetabolitter
- Proteasehæmmere
- Antikolesteræmiske midler
- Hypolipidæmiske midler
- Lipidregulerende midler
- Hydroxymethylglutaryl-CoA-reduktasehæmmere
- Angiotensin-konverterende enzymhæmmere
- Aspirin
- Simvastatin
- Ramipril
Andre undersøgelses-id-numre
- P-080647-01
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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