Study of Efficacy and Safety of CVAA489 in Hypertensive Patients

Novartis

Status and phase: Completed; Phase 4

Conditions: Essential Hypertension

Treatments: Drug: amlodipine/valsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02062645

CVAA489ATR04

Details and patient eligibility

About

The population that will be included in this study, will be regular Turkish hypertensive patients who are expected to consume sodium in high amounts. It is hypothesized that, in that population, amlodipine/valsartan will be effective at the same rate of blood pressure (BP) control rate as expected from literature.

Enrollment: 115 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, above 18 years of age
• Diagnosis of essential hypertension
• Newly diagnosed,
• Previously untreated, or Currently untreated (not on regular antihypertensive treatment during the previous at least 1-month period)
• Written informed consent

Exclusion criteria

• Known or suspected secondary hypertension
• eGFR lower than 30 mL/min
• Use of any other hypertension treatments during the enrollment and need for using the related treatments during the study phase
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. (i.e. valsartan, amlodipine, hydrochlorothiazide)
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days until the expected PD effect has returned to baseline, whichever is longer.Pregnant or nursing (lactating) women
• Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

amlodipine/valsartan

Experimental group

Description:

All patients will receive amlodipine/valsartan 5/160 mg daily in screening and up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (day 30) if their hypertension can not be controlled. The duration of treatment period is 8 weeks.

Treatment:

Drug: amlodipine/valsartan