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Safety and Efficacy Study of LHW090 in Resistant Hypertension Patients

9. desember 2020 oppdatert av: Novartis Pharmaceuticals

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

The purpose of the present study was to determine whether LHW090 displays the clinical safety and efficacy profile to support further development in patients with resistant hypertension.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

64

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Danmark
      • Gentofte, Danmark, DK 2820
        • Novartis Investigative Site
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • Novartis Investigative Site
    • California
      • North Hollywood, California, Forente stater, 91606
        • Novartis Investigative Site
    • Florida
      • Atlantis, Florida, Forente stater, 33462
        • Novartis Investigative Site
      • Daytona Beach, Florida, Forente stater, 32117
        • Novartis Investigative Site
      • Jacksonville, Florida, Forente stater, 32216
        • Novartis Investigative Site
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96814
        • Novartis Investigative Site
    • Tennessee
      • Knoxville, Tennessee, Forente stater, 37920
        • Novartis Investigative Site
  • Frankrike
      • Paris, Frankrike, 75015
        • Novartis Investigative Site
  • Nederland
      • Meibergdreef 9, Nederland, 1105 AZ
        • Novartis Investigative Site
  • Sveits
      • Basel, Sveits, 4031
        • Novartis Investigative Site
      • Lausanne, Sveits, 1011
        • Novartis Investigative Site
  • Tyskland
      • Berlin, Tyskland, 10098
        • Novartis Investigative Site
      • Duesseldorf, Tyskland, 40225
        • Novartis Investigative Site
      • Hannover, Tyskland, 30625
        • Novartis Investigative Site
      • Homburg, Tyskland, 66421
        • Novartis Investigative Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: LHW090 100 mg
LHW090 100 mg once daily for 28 days
Legemiddel: LHW090
Capsule - oral dose
Eksperimentell: LHW090 200 mg
LHW090 200 mg once daily for 28 days
Legemiddel: LHW090
Capsule - oral dose
Placebo komparator: Placebo
Matching placebo to LHW090 oral dose for 28 days
Legemiddel: Placebo
Capsule - oral dose

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Reported Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths
Tidsramme: 6 months
Number of participants with AEs, SAEs and deaths were assessed.
6 months
Change From Baseline in Mean Daytime Blood Pressure
Tidsramme: Baseline, day 27
Change in the 12 hour average of systolic blood pressure (SBP) measured by ambulatory blood pressure was defined as the 12 hour daytime average SBP on Day 28 minus the 12 hour daytime average SBP on Day -1. monitoring (ABPM). A negative change from baseline indicates improvement.
Baseline, day 27

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pharmacokinetics of LHW090/LHV527 in Plasma: Observe Maximum Plasma Concentration Following LHW090 at Steady State in Patients (Cmax)
Tidsramme: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
Blood samples were collected to assess Cmax.
Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
Pharmacokinetics of LHW090/LHV527 in Plasma: Time to Reach the Maximum Concentration After Administration of LHW090 (Tmax)
Tidsramme: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
Blood samples were collected to assess Tmax.
Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
Pharmacokinetics of LHW090/LHV527 in Plasma: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
Tidsramme: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
Blood samples were collected to assess AUClast.
Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
Pharmacokinetics of LHW090/LHV527 in Plasma: Last Measurable Plasma Concentration (Clast)
Tidsramme: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
Blood samples were collected to assess Clast.
Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
Pharmacokinetics of LHW090/LHV527 in Plasma:Tlast
Tidsramme: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
Blood samples were collected to assess Tlast.
Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. november 2015

Primær fullføring (Faktiske)

17. august 2017

Studiet fullført (Faktiske)

17. august 2017

Datoer for studieregistrering

Først innsendt

31. juli 2015

Først innsendt som oppfylte QC-kriteriene

31. juli 2015

Først lagt ut (Anslag)

4. august 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. januar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. desember 2020

Sist bekreftet

1. juni 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CLHW090X2202
  • 2015-001890-42 (EudraCT-nummer)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Patients, Resistant Hypertension

Kliniske studier på LHW090

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