essential hypertension MedDRA version: 12.1 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Interventions
Product Name: LCZ696
Product Code: LCZ696
Pharmaceutical Form: Film-coated tablet
CAS Number: 936623-90-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
CAS N
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Males and females patients, age 18 years of age and older. 3. Patients with mild-to-moderate systolic hypertension, untreated or currently taking antihypertensive therapy. 4. Untreated patients must have an office msSBP = 150 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Severe hypertension (msDBP =110 mmHg and/or msSBP = 180 mmHg). 2. History of angioedema, drug-related or otherwise, as reported by the patient. 3. Pregnant or nursing (lactating) women, where pregnancy is defined as a state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (= 5 mIU/ml). 4. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method (if accepted by local ethnics committee) or a barrier method plus a hormonal method. • Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent. • Reliable contraception should be maintained throughout the study and for 7 days after the study. • Woman 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 six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or have had surgical bilateral oophorectomy (with or without hysterectomy) 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. 5. 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. 6. Any history of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) 7. Current angina pectoris requiring pharmacological therapy (use of nitrates for the treatment of angina will be allowed). 8. Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled based on the investigator’s clinical judgment. It is recommended that patients currently being treated for diabetes mellitus be on stable dose of antidiabetic 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 Visit 1. 11. History or current diagnosis of the following cardiac abnormalities: • Second or third degree AV block without a pacemaker. • Clinically significant cardiac arrhythmias including active atrial fibrillation. • History of familial long QT syndrome or family history of torsade de pointe. 12. History of malignancy of any organ system, treated or untreated, within the past 5 years, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. 13. Severe liver disease such as cirrhosis or active hepatitis. 17. Any contraindication or history of hyperse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of 4 doses of AHU377 given once daily (50mg,100mg, 200mg and 400mg ) when given in combination with valsartan 320mg in patients with essential hypertension by testing the hypothesis that the reduction in mean sitting systolic blood pressure (msSBP) exhibits a dose response as compared to valsartan 320 mg monotherapy after 8 weeks of treatment.;Secondary Objective: • To evaluate the dose-response relationship in sitting diastolic blood pressure (msDBP) lowering of ascending doses of AHU377 in combination with valsartan 320 mg • To evaluate changes in mean 24 hour ambulatory SBP (maSBP), mean 24 hour ambulatory DBP (maDBP), daytime and nighttime msSBP/maDBP of ascending doses of AHU377 in combination with valsartan 320mg as compared to valsartan 320mg monotherapy ;Primary end point(s): The primary endpoint variable for this phase II study is the dose-response relationship in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with AHU377 + valsartan 320 mg as compared to valsartan 320mg monotherapy. | — |
Countries
Hungary, Slovakia, Spain
Outcome results
None listed