Safety and Efficacy Study of LHW090 in Resistant Hypertension Patients

NCT ID: NCT02515331

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-04
• Study Completion Date: 2017-08-17

Brief Summary

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.

Conditions

Patients, Resistant Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

LHW090 100 mg

LHW090 100 mg once daily for 28 days

Group Type: EXPERIMENTAL

LHW090

Intervention Type: DRUG

Capsule - oral dose

LHW090 200 mg

LHW090 200 mg once daily for 28 days

Group Type: EXPERIMENTAL

LHW090

Intervention Type: DRUG

Capsule - oral dose

Placebo

Matching placebo to LHW090 oral dose for 28 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Capsule - oral dose

Interventions

LHW090

Capsule - oral dose

Intervention Type: DRUG

Placebo

Capsule - oral dose

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Birmingham, Alabama, United States

Novartis Investigative Site

North Hollywood, California, United States

Novartis Investigative Site

Atlantis, Florida, United States

Novartis Investigative Site

Daytona Beach, Florida, United States

Novartis Investigative Site

Jacksonville, Florida, United States

Novartis Investigative Site

Honolulu, Hawaii, United States

Novartis Investigative Site

Knoxville, Tennessee, United States

Novartis Investigative Site

Gentofte Municipality, , Denmark

Novartis Investigative Site

Paris, , France

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Düsseldorf, , Germany

Novartis Investigative Site

Hanover, , Germany

Novartis Investigative Site

Homburg, , Germany

Novartis Investigative Site

Meibergdreef 9, Netherlands, Netherlands

Novartis Investigative Site

Basel, , Switzerland

Novartis Investigative Site

Lausanne, , Switzerland

Countries

United States; Denmark; France; Germany; Netherlands; Switzerland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=304

A Plain Language Trial Summary is available on novartisclinicatrials.com

Other Identifiers

2015-001890-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLHW090X2202

Identifier Type: -

Identifier Source: org_study_id