Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Ziel der Studie ist die Untersuchung der Sicherheit und Wirksamkeit einer vierwöchigen Behandlung mit LHW090 bei Patienten, die einen schwer einstellbaren Bluthochdruck haben. Die Patienten werden durch zufällige Auswahl entweder ein Scheinmedikament oder eine von zwei Dosierungen von LHW090 (100 mg oder 200 mg LHW090) einmal pro Tag erhalten, und zwar in Ergänzung zu ihrer bestehenden Behandlung des Bluthochdrucks. Die Studie besteht aus mehreren Phasen, jeder Studienteilnehmer wird zunächst an einer Screeningperiode teilnehmen, gefolgt von einer zweiwöchigen Anfangsphase mit einem Scheinmedikament, der vierwöchigen Behandlungsphase, sowie einer Abschlussuntersuchung am Studienende.
Malattie studiate(Fonte di dati: BASEC)
Resistenter Bluthochdruck
Health conditions
(Fonte di dati: WHO)
Patients, Resistant Hypertension
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
Behandlung mit LHW090 bzw. Placebo
Interventions
(Fonte di dati: WHO)
Drug: LHW090;Drug: Placebo
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
1. Schriftliches Einverständnis
2. Männliche/Weibliche Patienten, 40 bis 85 Jahre alt
3. ≥ 80% Compliance der Medikamenteneinnahme
Criteri di esclusione
(Fonte di dati: BASEC)
- Überempfindlichkeit gegen Studienmedikation.
- Nierenfunktionsstörung.
- Schwangerschaft.
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Inclusion Criteria:
- Male and female patients, age 40 to 85 years inclusive.
- • Patients with uncontrolled hypertension (here defined as having a mean daytime
systolic BP = 135 mmHg by ABPM at screening) despite treatment with a stable (at least
1 month) regimen that includes an optimal dose of an ARB plus a diuretic plus at least
one additional class of anti-hypertensive medication.
For the purposes of this trial, optimal doses of anti-hypertensive medications are defined
as:
- the highest dose listed in the clinical practice guideline from the American Society
for Hypertension and the International Society for Hypertension or
- the highest allowable prescribed dose per the manufacturer's label or
- the highest dose tolerated by an individual patient or
- the highest dose appropriate for an individual patient in the judgment of the
Investigator
- Subjects must weigh at least 45 kg to participate in the study and must have a body
mass index (BMI) within the range of 18-38 kg/m^2.
Exclusion Criteria:
- Patients with an estimated GFR <60 ml/min/1.73m^2.
- Use of angiotensin converting enzyme inhibitors (ACE-inhibitors). Note: Patients who
discontinue their ACE-inhibitor and substitute with an angiotensin receptor blocker
may be eligible to be re-screened provided their anti-hypertensive regimen has been
stable for at least 1 month. Any substitutions or changes to a patient's
anti-hypertensive regimen should be done under the guidance of the patient's treating
physician.
- Severe hypertension as defined by systolic blood pressure =180 mmHg or diastolic blood
pressure =110 mmHg at screening.
- A history of secondary hypertension of any etiology including but not limited to
unilateral or bilateral renal artery stenosis, polycystic kidney disease, coarctation
of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, and
drug-induced hypertension.
- Known current significant left ventricular outflow obstruction, such as obstructive
hypertrophic cardiomyopathy or significant severe valvular disease on prior or current
echocardiogram).
- A history of known moderate or malignant retinopathy defined as moderate (retinal
signs of hemorrhage), microaneurysms, cotton-wool spots, hard exudates, or a
combination thereof) or malignant (signs of moderate retinopathy plus swelling of the
optic disk). Patients with a stable ophthalmologic history in the past 6 months are
eligible.
- To facilitate ABPM assessment, an upper arm circumference greater than 42 cm.
- History within the previous 6 months of myocardial infarction, coronary artery bypass
graft (CABG), percutaneous coronary intervention (PCI), hypertensive encephalopathy,
stroke, or transient ischemic attack (TIA).
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
after conception and until the termination of gestation, confirmed by a positive hCG
laboratory test.
• Women of child-bearing potential
-
Altre informazioni sulla sperimentazione
Data di registrazione della sperimentazione
31 lug 2015
Inserimento del primo partecipante
4 nov 2015
Stato di reclutamento
Completed
Titolo scientifico
(Fonte di dati: WHO)
A Randomized, Sponsor Open, Site and Subject Double Blind, Parallel Group, Placebo-controlled Study to Evaluate the Safety and Efficacy of LHW090 After 4 Weeks Treatment in Patients With Resistant Hypertension
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
Fase
(Fonte di dati: WHO)
Phase 2
Punti finali primari
(Fonte di dati: WHO)
Change From Baseline in Mean Daytime Blood Pressure;Number of Participants With Reported Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths
Punti finali secondari
(Fonte di dati: WHO)
Pharmacokinetics of LHW090/LHV527 in Plasma:Tlast;Pharmacokinetics of LHW090/LHV527 in Plasma: Last Measurable Plasma Concentration (Clast);Pharmacokinetics of LHW090/LHV527 in Plasma: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast);Pharmacokinetics of LHW090/LHV527 in Plasma: Time to Reach the Maximum Concentration After Administration of LHW090 (Tmax);Pharmacokinetics of LHW090/LHV527 in Plasma: Observe Maximum Plasma Concentration Following LHW090 at Steady State in Patients (Cmax)
Contatto per informazioni
(Fonte di dati: WHO)
Please refer to primary and secondary sponsors
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
ancora nessuna informazione disponibile
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Basilea, Losanna
Paesi di esecuzione
(Fonte di dati: WHO)
Denmark, France, Germany, Netherlands, Switzerland, United States
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Dr. Kashan Ahmed
+41 79 586 83 15
kashan.ahmed@novartis.com
Contatto per informazioni generali
(Fonte di dati: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Commission
cantonale d’Éthique de la Recherche sur l’être humain Vaud (CER-VD)
Data di autorizzazione da parte della commissione d’etica
16.03.2016
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2015-00212
Secondary ID (Fonte di dati: WHO)
2015-001890-42
CLHW090X2202
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