- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00994253
Evaluating the Effect of Aliskiren Versus HCTZ on Coronary Flow Reserve in Hypertensive Type II Diabetics
A Prospective, Randomized, Open-label Clinical Trial to Evaluate the Effect of Tekturna (Aliskiren), Angiotensin Inhibitors, Diuretics, and Calcium Channel Blockers on Coronary Flow Reserve in Patients With Type II Diabetes and Hypertension
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
Michigan
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Royal Oak, Michigan, Forente stater, 48073
- William Beaumont Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age 18-85
- Diagnosed with Type II Diabetes and Hypertension
- Taking either ACE or ARB in addition to any other antihypertensive medication excluding aliskiren
- Blood Pressure >130/80
Exclusion Criteria:
- Serum Potassium >5.2 mmol/L
- History of any cardiovascular event (stroke, TIA, unstable angina, CABG, percutaneous coronary intervention, hospitalization due to HF) during the 3 months prior to Visit 1.
- History of MI
- Documented ejection fraction of <50%
- Hypertension (at Screening): any patient with msSBP ≥ 180 mmHg or msDBP ≥ 110 mmHg
- Congestive Heart Failure NYHA class III and IV
- Concomitant treatment with two (2) or more renin-angiotensin-aldosterone system blocking agents, e.g. ACE inhibitor, ARB or aldosterone-antagonist.
- Unstable serum creatinine
- Second (II) or third (III) degree heart block without a pacemaker
- Concurrent potentially life threatening arrythmia or other uncontrolled arrythmia
- Clinically significant valvular heart disease
- Known renal artery stenosis
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drugs including, but not limited to, any of the following:
- History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection (patients with previous bariatric surgery>6 months prior to Visit 1 are allowed to participate).
- Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase.
- Evidence of hepatic disease as determined by any one of the following: SGPT value exceeding 3x Upper Limit of Normal (ULN) at Visit 1, a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt.
- History of malignancy other than basal cell skin cancer that is likely to reduce the subject's life span to less than 2 years.
- Any concurrent life threatening condition with a life expectancy less than 2 years
- History or evidence of drug or alcohol abuse with the last 12 months
- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- History of hypersensitively to any of the study drugs or to medications belonging to the same therapeutic class as the study drugs as well as known or suspected contraindications to the study drugs
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- Any condition that in the opinion of the investigator would jeopardized the evaluation of efficacy or safety
- Persons directly involved in the execution of this protocol
- Pregnant or nursing (lactating) women
- Women of Child Bearing Potential unless post menopausal for at least one year, surgically sterile or using effective methods of contraception as defined by local Health Authorities.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Aliskiren
Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg |
Aliskiren will be prescribed at 150mg po per day.
If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.
All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily.
Andre navn:
|
Aktiv komparator: Hydrochlorothiazide
HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg |
Hydrochlorothiazide will be prescribed at 12.5 po per day.
If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.
All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The primary objective is to assess the effect of a multimodal drug therapy regimen including the renin inhibitor Tekturna (aliskiren), an ACE inhibitor, and a calcium channel blocker on coronary flow reserve (CFR) in hypertensive Type II diabetics.
Tidsramme: 6 months
|
CFR will be assessed by a PET-based imaging technique.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Secondary measures include evaluation of serum and urine biomarkers related to endothelial function, the renin-angiotensin system, oxidative stress, and inflammation.
Tidsramme: 6 months
|
Biomarkers include asymmetric dimethylarginine, B-type natriuretic peptide, plasma renin activity, high-sensitivity C-reactive protein, adiponectin, aldosterone, angiotensinogen, and hemoglobin A1c.
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6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Pamela A Marcovitz, MD, Beaumont Health System, Royal Oak
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Glukosemetabolismeforstyrrelser
- Metabolske sykdommer
- Sykdommer i det endokrine systemet
- Sukkersyke
- Hypertensjon
- Diabetes mellitus, type 2
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Antihypertensive midler
- Natriuretiske midler
- Membrantransportmodulatorer
- Diuretika
- Natriumklorid Symporter-hemmere
- Hydroklortiazid
Andre studie-ID-numre
- 2009-083
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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