Study of the safety and efficacy of LCZ696 on arterial stiffness in elderly patients with hypertensio

• Conditions: Elderly Hypertensive patients; MedDRA version: 14.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-002899-14-ES
• Lead Sponsor: ovartis Farmaceutica S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-21
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed
2. Male and female patients > or = 60 years of age.
3. Patients with essential hypertension, untreated or currently taking antihypertensive therapy.
4. Untreated patients must have an office msSBP > or = 150 mmHg and <180 mmHg at Visit 101 and Visit 201 if they are newly diagnosed or have not been treated with antihypertensive drugs for the 4 weeks prior to Visit 1.
5. Treated patients must have an office msSBP > or = 140 mmHg and <180 mmHg at Visit 102 (or Visit 103) and msSBP > or = 150 mmHg and <180 mmHg at Visit 201 if they have been treated with antihypertensive drugs for the 4 weeks prior to Visit 1.
6. All patients must have pulse pressure >60 mmHg at Visit 201. Pulse pressure is defined as msSBP- msDBP.
7. Patients must have a difference in msSBP of +/-15 mmHg betweenv Visit 201 (randomization) and the visit immediately prior to Visit 201.
8. Patients with the ability to communicate and comply with all study requirements and demonstrate good medication compliance (> or = 80% compliance rate) during the run-in epoch (Epoch 2).
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 172
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 260

Exclusion Criteria

1. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 5 times the terminal half-life of study treatment. Highly effective contraception methods include:
? Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
? Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
? Male sterilization (at least 6 m prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject
? Combination of any two of the following (a+b or a+c, or b+c):
a. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
? In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment
b. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
c. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository
? Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
2. Malignant or severe hypertension (grade 3 of WHO classification; msDBP > or =110 mmHg and/or msSBP > or =180 mmHg).
3. History of angioedema, drug-related or otherwise.
4. History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing?s disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
5. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke.
6. History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
7. Current angina pectoris requiring pharmacological therapy (other than patients on a stable dose of oral or topical nitrates).
8. Type 1 or Type 2 diabetes mellitus not well controlled based on the investigator?s clinical judgment. Patients currently being treated for diabetes mellitus should be on stable dose of anti-diabetic medication for at least 4 weeks prior to Visit 1.
9. Previous or current diagnosis of heart failure (NYHA Class II-IV).
10. Clinically significant valvular heart disease at Vis

Study & Design

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