A study evaluating the safety and efficacy of LHW090 in patients with resistant hypertensio

Phase 1

• Conditions: Resistant hypertension; MedDRA version: 19.0Level: LLTClassification code 10015491Term: Essential hypertension, unspecifiedSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-001890-42-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-15
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed.
2. Male and female patients, age 40 to 85 years inclusive.
3. Demonstrating a = 80% medication compliance rate during the single-blind run-in period.
4. Patients with uncontrolled hypertension (here defined as having a daytime systolic BP = 135 mmHg by ABPM at screening) despite
treatment with a stable (at least 1 month) regimen that includes an optimal doses of an ARB plus a diuretic (thiazide or loop) plus at least one class of anti-hypertensive medication
For the purposes of this trial, optimal doses of anti-hypertensive medications are defined as:
? a) the highest dose listed in the clinical practice guideline from the American Society for Hypertension and the International Society for Hypertension [Weber, et al. 2014] or
? b) the highest allowable prescribed dose per the manufacturer's label or
? c) the highest dose tolerated by an individual patient or
? d) the highest dose appropriate for an individual patient in the judgment of the Investigator
5. Subjects must weigh at least 45 kg to participate in the study and must have a body mass index (BMI) within the range of 18-40kg/m2.
6. Able to communicate well with the investigator, to understand and comply with the requirements of
the study.

Other protocol defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer; or longer if
required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
3. Patients with an estimated GFR <60 ml/min/1.73m2 at screening using the MDRD equation.
4. 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.
5. History of angioedema, drug related or otherwise, as reported by the patient.
6. Clinically significant ECG abnormalities at screening as determined by the Investigator.
7. Severe hypertension as defined by an office systolic blood pressure = 180 mmHg or diastolic blood pressure =110 mmHg at screening or baseline.
8. 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. If the
patient has not been evaluated for secondary hypertension, investigators are responsible to evaluate all potential secondary causes of
hypertension considering clinical history, physical examination, laboratory investigations or other relevant diagnostic measures in
accordance with current practices and clinical guidelines before entering the patient into the study.
9. Known current significant left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or significant severe valvular disease on prior or current echocardiogram).
10. A history of known moderate or malignant hypertensive 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. Any new or progressive retinal changes, acute glaucoma or
other ophthalmologic conditions within the past 6 months should be evaluated by the treating ophthalmologist during screening.
11. To facilitate ABPM assessment of daytime readings, an upper arm circumference greater than 42 cm or third shift or overnight workers.
12. 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).
13. Hemoglobin levels below 9.0 g/dL at screening.
14. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or
untreated, within the past 1 year, regardless of whether there is evidence of local recurrence or metastases.
15. Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation.
16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state o

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified