A phase II, randomized, double-blind, placebo and active controlled, parallel group, multi-center, dose ranging study to evaluate the efficacy and safety of LCI699 compared to placebo after 8 weeks treatment in patients with resistant hypertension.

• Conditions: resistant hypertension; MedDRA version: 9.1Level: LLTClassification code 10020772Term: Hypertension

• Registration Number: EUCTR2008-007338-23-IS
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. An established diagnosis of hypertension with MSSBP > 140mmHg and < 180 mmHg on current antihypertensive treatment measured within two (2) weeks of randomization. This includes subjects with diabetes and/or chronic kidney disease.
2. Resistant hypertension as defined by the failure to achieve goal blood pressure in patients who are adhering to optimal doses of a stable three-drug regimen that includes a diuretic for a period of at least 4 weeks.
3. Male or non-fertile female patients 18 to 75 years of age (inclusive)
o Female subjects must have been surgically sterilized (oophorectomy with or without hysterectomy) at least 6 months prior to screening. Surgical sterilization procedures must be supported with clinical documentation made available to sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF.
o Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion. Menopause will be confirmed by a plasma FSH level of =40 IU/L
o Male subjects must be using a double-barrier local contraception, i.e., spermicidal gel plus condom, for the entire duration of the study, up to Study Completion visit, and refrain from fathering a child or donating sperm in the three (3) months following last study drug administration.
4. Morning plasma cortisol (sampled between 08:00 and 09:00) > 250 nM
5. Able to provide written informed consent prior to study participation.
6. Able to communicate with the investigator and willing to comply with the requirements of the study.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

For full list, please refer to the protocol.

1. Severe hypertension (MSSBP > 180 mmHg or MSDBP > 110 mmHg) at screening.
2. Pregnant or nursing (lactating) women, where pregnancy confirmed by a positive hCG laboratory test (>5 mIU/ml).
3. Recent history (within last 6 months) of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack (TIA).
4. Clinically significant cardiac conduction defects (eg, 3rd degree atrioventricular [AV] block, left bundle branch block [LBBB], sick sinus syndrome, atrial fibrillation or flutter).
5. Implanted cardioverter defibrillator (ICD) that has fired for any arrhythmia within 3 months of screening or implanted pacemakers.
6. Clinically significant valvular heart disease.
7. A history of secondary hypertension of any etiology (eg, renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing’s disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension, obstructive sleep apnea, etc).
8. Known moderate or maliganant retinopathy defined as: moderate (retinal signs of hemorrahage, microaneurysm, cotton-wool spots, hard exudates, or a combination thereof) or maliganant (signs of moderate retinopathy plus swelling of the optic disk).
9. Type 1 diabetes.
10. Type 2 diabetes mellitus with poor glucose control as defined by HbA1c >9%.

Study & Design

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