A multi-center, randomized, double-blind, placebo and active controlled, parallel group, dose finding study to evaluate the efficacy and safety of LCI699 compared to placebo after 8 weeks treatment in patients with essential hypertensio

• Conditions: Essential Hypertension; MedDRA version: 9.1Level: LLTClassification code 10015488Term: Essential hypertension

• Registration Number: EUCTR2008-003139-19-FR
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-15
• Last Update Posted: 26 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

1. Written informed consent to participate in the study.
2. Male, non-fertile female: a non-fertile female is defined as post menopausal (12 months of natural spontaneous amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml); 6 weeks post bilateral oophorectomy with or without hysterectomy (in case of oophrectomy only, non-fertile status is considered only when the reproductive status has been confirmed by hormone level assessment); post hysterectomy; or sterilized by tubal ligation.
3. Age from 18 up to 75 years inclusive.
4. Patients with mild-to-moderate uncomplicated essential hypertension, untreated including newly diagnosed and/or those with known hypertension history but who have not been treated for at least 4 weeks prior to Visit 1, or treated who are currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs). Therapy with a fixed dose combination of two active substances is considered 2 drugs.
5. Untreated or treated patients must meet the following office BP criteria:
• Untreated patients must have a MSDBP = 95 mm Hg and < 110 mmHg at Visits 1-3.
• Treated patients must have a MSDBP = 90 mmHg and < 110 mmHg at Visits 1.
(screening) & 2 (after washout) and a MSDBP = 95 mmHg and < 110 mmHg at Visit 3.
6. Ability to communicate and comply with all study requirements and demonstrating a good medication compliance (= 80% compliance rate) during the run-in period.
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

1. All women of child bearing potential.
2. Pregnant or nursing 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.
3. Female patients on hormone replacement therapy.
4. Severe hypertension.
5. History or evidence of a secondary form of hypertension.
6. Known moderate or malignant retinopathy.
7. History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind, troke, transient ischemic attack (TIA), carotid artery stenosis, aortic aneurysm or peripheral arterial disease.
8. Type 1 or type 2 diabetes mellitus.
9. Clinically significant valvular heart disease.
10. Previous or current diagnosis of congestive heart failure.
11. History or current diagnosis of the following cardiac electric abnormalities indicating significant risk of safety for patients participating in the study such as:
• Second or third degree AV block without a pacemaker.
• Concomitant clinically significant cardiac arrhythmias.
• History of familial long QT syndrome or family history of torsade de pointe.
12. History of malignancy of any organ system, treated or untreated.
13. Liver disease such as cirrhosis or chronic active hepatitis.
14. Any surgical or medical conditions that may significantly alter the absorption, distribution, metabolism or excretion of any drug substance.
15. Any surgical or medical conditions, not identified in the protocol that in the opinion of the investigator or the Novartis monitor, place the patient at higher risk from his/her participation in the study.
16. Patients unwilling or not able to discontinue safely the use of current antihypertensive medications during the study period.
17. Any contraindication or history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
18. Chronic oral or parenteral corticosteroid treatment within 4 weeks prior to Visit 1.
19. Treatment with potassium supplement or potassium sparing diuretics required during the course of study.
20. Treatment with potent CYP3A4 inhibitors during the study period.
21. Use of other investigational drugs at Visit 1, or within 30 days or 5 half-lives of Visit 1, whichever is longer, unless local health authority guidelines mandate a longer period.
22. Any of the significant laboratory abnormalities:
23. History of active substance abuse within the past 2 years and potentially unreliable patients.
24. Patients with night-shift employment.
25. Persons directly involved in the execution of this clinical study.
26. Arm circumference > 42 cm, due to ABPM assessment.

Study & Design

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