Safety and Efficacy of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension

Condition(s) targeted: Essential Hypertension

Intervention: Valsartan (Drug); Amlodipine (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Sponsor

This study is designed to compare the efficacy, tolerability, and safety of the combination valsartan/amlodipine 160/5mg versus amlodipine 10mg in patients with essential hypertension not adequately controlled [defined as mean sitting systolic blood pressure (MSSBP) ≥ 130 mmHg and ≤ 160 mmHg] on amlodipine 5mg alone.

The study will evaluate the efficacy and tolerability of both treatment groups by providing data evaluating blood pressure lowering efficacy and the proportion of patients developing peripheral edema.

Official title: A Double-Blind, Randomized, Multicenter, Parallel Group Study to Evaluate the Efficacy, Tolerability, and Safety of Treatment With the Combination of Valsartan/Amlodipine 160/5 mg Compared to Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Controlled With Amlodipine 5 mg Alone

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Change in mean sitting systolic blood pressure (MSSBP) after 8-week treatment

Incidence of peripheral edema quantified as adverse event (AE) reported peripheral edema after 8-week treatment

Secondary outcome:

Change in mean sitting diastolic blood pressure (MSDBP) after 8-week treatment

Change from baseline in MSSBP and MSDBP after 4 and 12 weeks of treatment

Systolic blood pressure responder rate (defined as MSSBP < 130 mmHg or ≥ 20 mmHg reduction from baseline) at week 4, 8, and 12

Proportion of patients who reach systolic blood pressure control (defined as MSSBP < 130mmHg) at week 4, 8, and 12

Proportion of patients who reach overall blood pressure control (defined as BP <140/90 mmHg for non-diabetic patients and < 130/80 mmHg for diabetic patients) at week 4, 8, and 12

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female outpatients ≥ 55 years of age

- Patients with essential hypertension measured using a validated automated

oscillometric device at Visit 1

- Non-treated patients must have a MSSBP ≥140 mmHg and ≤ 160 mmHg

- Patients pre-treated on monotherapy prior to Visit 1 must have MSSBP ≤ 160 mmHg

- To be eligible for randomization at Visit 2 (Day 1) all patients must have a MSSBP

≥130 mmHg and ≤ 160 mmHg

- No peripheral edema at Visit 2 (randomization)

- Written informed consent to participate in this study prior to any study procedures

Exclusion Criteria:

- Women of child-bearing potential, defined as all women physiologically capable of

becoming pregnant

- Known or suspected contraindications, including history of allergy or hypersensitivity

to angiotensin receptor blockers, calcium channel blockers, or to drugs with similar chemical structures

- Patients taking more than 1 antihypertensive medication at Visit 1

- Administration of any agent indicated for the treatment of hypertension after Visit 1

with the exception of pre-treated patients that require tapering down of anti-hypertensive treatments. For patients with previous antihypertensive medication that require a gradual downward titration, the tapering down should be done according

to manufacturers instructions and last dose should be taken by week - 2 prior to

randomization

- MSSBP > 180mmHg or MSDBP  110 mmHg at any time between Visit 1 and Visit 2

- Evidence of a secondary form of hypertension, including but not limited to any of the

following: coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, polycystic kidney disease, or pheochromocytoma

- History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic

attack, myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) 12 months prior to Visit 1

- History of heart failure Grade II - IV according to the NYHA classification

- Second or third degree heart block with or without a pacemaker

- Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia

- Concomitant unstable angina pectoris

- Clinically significant valvular heart disease

- Patients with Type 1 diabetes mellitus

- Patients with Type 2 diabetes mellitus who are not well controlled based on the

investigator's judgment. It is recommended that Type 2 diabetic patients are adequately controlled and, if treated with medication, be on a stable dose of oral anti-diabetic medication for at least 4 weeks prior to Visit 1.

Other protocol-defined inclusion/exclusion criteria may apply.

Novartis Investigative Site, Finland, Joensuu FI-80100, Finland

Sites in Germany, Germany

Starting date: January 2007
Last updated: August 13, 2007