Back to overview
SNCTP000001775 | NCT02515331 | BASEC2015-00212

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

Data source: BASEC (Imported from 03.05.2024), WHO (Imported from 03.05.2024)
Changed: Dec 23, 2023, 4:47 PM
Disease category: Arterial and venous diseases including deep venous thrombosis and lung embolism

Brief description of trial (Data source: 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.

Health conditions investigated(Data source: BASEC)

Resistenter Bluthochdruck

Health conditions (Data source: WHO)

Patients, Resistant Hypertension

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Behandlung mit LHW090 bzw. Placebo

Interventions (Data source: WHO)

Drug: LHW090;Drug: Placebo

Criteria for participation in trial (Data source: BASEC)

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

Exclusion criteria (Data source: BASEC)

- Überempfindlichkeit gegen Studienmedikation.
- Nierenfunktionsstörung.
- Schwangerschaft.

Inclusion/Exclusion Criteria (Data source: 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

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02515331

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02515331
Further information on trial

Date trial registered

Jul 31, 2015

Incorporation of the first participant

Nov 4, 2015

Recruitment status

Completed

Academic title (Data source: 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

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).

Phase (Data source: WHO)

Phase 2

Primary end point (Data source: WHO)

Change From Baseline in Mean Daytime Blood Pressure;Number of Participants With Reported Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths

Secundary end point (Data source: 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)

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

https://clinicaltrials.gov/ct2/show/results/NCT02515331

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Basel, Lausanne

Countries (Data source: WHO)

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

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

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

Contact for general information (Data source: WHO)

Novartis Pharmaceuticals
Novartis Pharmaceuticals

Contact for scientific information (Data source: WHO)

Novartis Pharmaceuticals
Novartis Pharmaceuticals

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Commission cantonale d’Éthique de la Recherche sur l’être humain Vaud (CER-VD)

Date of authorisation by the ethics committee

16.03.2016

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2015-00212

Secondary ID (Data source: WHO)

2015-001890-42
CLHW090X2202
Back to overview