A multicenter, double-blind, randomized, parallel-group study to evaluate the safety, tolerability, and efficacy of once daily amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg or to amlodipine 5 mg once daily in elderly patients with essential hypertension not adequately controlled after four weeks on amlodipine 5 mg once daily - ND

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

• Registration Number: EUCTR2007-004726-24-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-12
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 670

Inclusion Criteria

Inclusion criteria 1. Patients must give written informed consent before any assessment is performed. 2. Male or female ages 65 years and older. 3. Diagnosed as having hypertension: At Visit 1/Screening, naïve patients MUST have a mean seated SBP ≥ 155 mmHg and <180 mmHg; patients undergoing washout MUST have a mean seated SBP <180 mmHg. At Visit 2/Single-blind run-in entry, all patients MUST have a mean seated SBP ≥ 155 mmHg and <180 mmHg. At Visit 3/Core double-blind treatment period entry, all patients MUST have a mean seated SBP ≥145 mmHg and <180 mmHg. 4. Ability to communicate and comply with all study requirements, including measuring their blood pressure at home, daily as instructed, using the home blood pressure monitor, provided by the Sponsor. 5. Female patients must be post-menopausal for at least one year.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

Exclusion criteria 1. Patients with severe hypertension (mean seated SBP ≥180 mmHg and/or a mean seated DBP ≥110 mmHg). 2. Patients who have a history of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheocromocytoma, etc.). 3. Patients receiving three or more antihypertensive drugs. Dual fixed dose combination therapy will be considered as two antihypertensive drugs. 4. Administration of any agent indicated for the treatment of hypertension after Visit 1, with the permitted exception of those antihypertensive medications requiring tapering down (e.g. betablocker and/or clonidine) commencing with Visit 1. 5. Known moderate or malignant retinopathy. Moderate defined as: retinal signs of hemorrhage, microaneurysm, cotton-wool spot, hard exudates, or a combination thereof; malignant defined as: signs of moderate retinopathy plus swelling of the optic disk. 6. Known or suspected contraindications, including history of allergy or hypersensitivity to ARBs, CCBs, or to drugs with similar chemical structures. 7. History of cerebrovascular accident, thrombotic stroke, or transient ischemic attack. 8. Significant history of coronary artery disease (CAD) such as any history of myocardial infarction (MI), angina pectoris, and all types of revascularization procedures. 9. History of or diagnosis of congestive heart failure Grade II-IV according to the NYHA classification. 10. Clinically significant valvular heart disease. 11. All patients with Type 1 diabetes mellitus and those patients with Type 2 diabetes mellitus who, in the opinion of the investigator, are not well controlled. Patients who need oral anti-diabetic medication to adequately control their Type 2 diabetes should be on a stable dose of oral antidiabetic medication for at least 4 weeks prior to Visit 1. 12. Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia. 13. Second or third degree heart block with or without a pacemaker. PLS SEE PROT.

Study & Design

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