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

Novartis

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: Valsartan/amlodipine 160/5 mg; Drug: Placebo; Drug: Valsartan 160 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01001572

CVAA489A2317

Details and patient eligibility

About

This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill combination in patients with uncomplicated essential hypertension not adequately controlled (MSDBP ≥90 mmHg and <110 mmHg) on valsartan 160 mg alone.

Enrollment: 932 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must give written informed consent

• Male or female ages 18 or older and less than 86 years

• Diagnosed as having essential diastolic hypertension, as follows:

  • Visit 2/Single-blind run-in entry, all participants MUST have a MSDBP ≥ 95 mmHg and < 100 mmHg
  • At Visit 3/Core double-blind treatment period entry, all patients MUST have a MSDBP >=90 mmHg and <110 mmHg

Exclusion criteria

• Severe hypertension
• Evidence of secondary form of hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma or polycystic kidney disease )
• Malignant hypertension
• Administration of any agent indicated for the treatment of hypertension after Visit 1
• Known moderate or malignant retinopathy.
• Known or suspected contraindications, including history of allergy or hypersensitivity to Angiotensin II Receptor Blockers (ARBs), Calcium Channel Blockers (CCBs), or to drugs with similar chemical structures
• History of hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack, myocardial infarction or all types of revascularization, angina pectoris of any type, including unstable angina
• History of heart failure Grade II-IV according to New York Heart Association (NYHA) classification
• Second of third degree heart block regardless of the use of a pacemaker, concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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932 participants in 3 patient groups

Valsartan 160 mg

Active Comparator group

Description:

One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks

Treatment:

Drug: Valsartan 160 mg

Drug: Placebo

Valsartan/amlodipine 160/5 mg

Experimental group

Description:

One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks

Treatment:

Drug: Valsartan/amlodipine 160/5 mg

Drug: Placebo

Single-Blind Run-In Valsartan 160 mg

Other group

Description:

Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.

Treatment:

Drug: Valsartan 160 mg