Study of Efficacy and Safety of CVAA489 in Hypertensive Patients

Essential Hypertension Clinical Trial

Official title:

A Single-Arm Open-Label Multicenter Phase IV Clinical Trial to Explore the Blood Pressure Lowering Effect of Exforge® (Amlodipine/Valsartan: AMLO/VAL) in Hypertensive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062645
• Other study ID #: CVAA489ATR04
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2014
• Last updated: July 21, 2016
• Start date: February 2014
• Est. completion date: September 2015

Study information

• Verified date: July 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• amlodipine/valsartan
Fixed combination of amlodipine and valsartan in tablet; 160/5 mg, 160/10 mg

Locations

Country	Name	City	State
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Canakkale
Turkey	Novartis Investigative Site	Fatih / Istanbul
Turkey	Novartis Investigative Site	Kinikli / Denizli
Turkey	Novartis Investigative Site	Kocaeli
Turkey	Novartis Investigative Site	Malatya
Turkey	Novartis Investigative Site	Mersin
Turkey	Novartis Investigative Site	Talas / Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with control rate of blood pressure (BP)	Control rate of BP defined as BP lower than 140/90 mmHg.	2 months	No
Secondary	Change from baseline in systolic blood pressure (SBP) in patients treated with valsartan/amlodipine at 2 months	All patient will have office BP monitoring in the clinic in each visit.	baseline, 2 months	No
Secondary	Change from baseline in diastolic blood pressure (DBP) in patients treated with valsartan/amlodipine at 2 months	All patient will have office BP monitoring in the clinic in each visit.	baseline, 2 months	No
Secondary	Change from baseline control rate of BP in patients with high sodium intake at 2 months	All patient will have office BP monitoring in the clinic in each visit. Control rate of BP defined as BP lower than 140/90 mmHg.	baseline, 2 months	No
Secondary	Change from baseline in SBP and DBP in patients with high sodium intake	All patients will have office BP monitoring in the clinic in each visit	baseline, 2 months	No
Secondary	Number of patients with total adverse events, serious adverse events and death to assess tolerability of valsartan/amlodipine		2 months	Yes