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 hypertensio
- Conditions
- resistant hypertension / difficult-to-treat hypertension10057166
- Registration Number
- NL-OMON43264
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
- Written informed consent must be obtained before any assessment is performed.
- Male and female patients, age 40 to 85 years inclusive.
- Demonstrating a >= 80% medication compliance rate during the singleblind run-in period.
- 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.
- Subjects must weigh at least 45 kg to participate in the study and must have a body mass index
(BMI) within the range of 18-40 kg/m2.;See protocol for more details and other inclusion criteria that may apply.
- 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.
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- Patients with an estimated GFR <60 ml/min/1.73m2 at screening using the MDRD equation.
- Use of angiotensin converting enzyme inhibitors (ACE-inhibitors).
- History of angioedema, drug related or otherwise, as reported by the patient.
- Clinically significant ECG abnormalities at screening as determined by the Investigator.
- Severe hypertension as defined by an office systolic blood pressure >= 180 mmHg or diastolic blood pressure >=110 mmHg at screening or baseline.
- 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 HT, 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.
- Known current significant left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or significant severe valvular disease (on prior or current echocardiogram).
- 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).
- 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
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential.
- Sexually active males must use a condom during intercourse while taking drug and for
1 week after stopping study medication and should not father a child in this period.;See protocol for more details and other exclusion criteria that may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy variable will be the change in the 12 hour average of<br /><br>systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM)<br /><br>28 days following the start of treatment.<br /><br><br /><br>Safety endpoints (adverse events, serious adverse events) up to and including<br /><br>end of study assessments</p><br>
- Secondary Outcome Measures
Name Time Method <p>PK parameters on Day 28 (Cmax, Tmax, AUClast, AUC0-t)</p><br>