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NCT02515331 | SNCTP000001775

Ziel der Studie ist die Untersuchung der Sicherheit und Wirksamkeit einer vierwöchigen Behandlung mit LHW090 bei Patienten mit schwer einstellbarem Bluthochdruck.

Datenbasis: BASEC (Import vom 24.10.2017), WHO (Import vom 22.10.2017)
Geändert: 15.10.2017

Zusammenfassende Beschreibung der Studie (Datenquelle: 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.

Untersuchte Krankheiten (Datenquelle: BASEC)

Resistenter Bluthochdruck

Health conditions (Datenquelle: WHO)

Patients, Resistant Hypertension;Patients, Resistant Hypertension

Untersuchte Intervention (z.B. Medikament, Therapie, Kampagne) (Datenquelle: BASEC)

Behandlung mit LHW090 bzw. Placebo

Interventions (Datenquelle: WHO)

Drug: LHW090;Drug: Placebo;Drug: LHW090;Drug: Placebo

Kriterien zur Teilnahme an der Studie (Datenquelle: BASEC)

1. Schriftliches Einverständnis 2. Männliche/Weibliche Patienten, 40 bis 85 Jahre alt 3. ≥ 80% Compliance der Medikamenteneinnahme

Ausschlusskriterien (Datenquelle: BASEC)

- Überempfindlichkeit gegen Studienmedikation. - Nierenfunktionsstörung. - Schwangerschaft.

Inclusion/Exclusion Criteria (Datenquelle: 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
;
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

Weitere Angaben zur Studie im WHO-Primärregister

https://clinicaltrials.gov/show/NCT02515331

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02515331

Weitere Informationen zur Studie

Registrationsdatum der Studie

31.07.2015

Einschluss der ersten teilnehmenden Person

04.11.2015

Rekrutierungsstatus

Completed

Wissenschaftlicher Titel (Datenquelle: 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

Studientyp (Datenquelle: WHO)

Interventional

Phase (Datenquelle: WHO)

Phase 2

Primäre Endpunkte (Datenquelle: WHO)

Number of patients with reported adverse events receiving multiple oral dosing of LHW090 as assessment of safety and tolerability;Number of patients with mean daytime blood pressure;Number of patients with reported adverse events receiving multiple oral dosing of LHW090 as assessment of safety and tolerability;Number of patients with mean daytime blood pressure

Sekundäre Endpunkte (Datenquelle: WHO)

Pharmacokinetics of LHW090/LHV527 in plasma: observe maximum plasma concentration following LHW090 at steady state in patients;Pharmacokinetics of LHW090/LHV527 in plasma: time to reach the maximum concentration after administration of LHW090 (Tmax);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: area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (AUC0-t);Pharmacokinetics of LHW090/LHV527 in plasma: area under the plasma concentration-time curve from time zero to the end of the dosing interval tau (AUCtau)

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors

Studiendurchführungsorte

Durchführungsorte in der Schweiz (Datenquelle: BASEC)

Basel, Lausanne

Durchführungsländer (Datenquelle: WHO)

Denmark, France, Germany, Netherlands, Switzerland, United States

Kontakt für weitere Auskünfte zur Studie

Angaben zur Kontaktperson in der Schweiz (Datenquelle: BASEC)

Dr. Kashan Ahmed
+41 79 586 83 15
kashan.ahmed@novartis.com

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Novartis Pharmaceuticals;Novartis Pharmaceuticals
Novartis Pharmaceuticals;Novartis Pharmaceuticals

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Novartis Pharmaceuticals;Novartis Pharmaceuticals
Novartis Pharmaceuticals;Novartis Pharmaceuticals

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

Novartis Pharmaceuticals

Weitere Studienidentifikationsnummern

BASEC ID (Datenquelle: BASEC)

2015-00212

Secondary ID (Datenquelle: WHO)

2015-001890-42;CLHW090X2202