A Study to Evaluate the Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled on Monotherapy

Hypertension Clinical Trial

Official title:

A Double-blind, Randomized, Multicenter Study to Evaluate the Effectiveness of the Combination of Valsartan & Amlodipine in Hypertensive Patients Not Controlled on Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327145
• Other study ID #: CVAA489A2401
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2006
• Last updated: November 16, 2016
• Start date: March 2006
• Est. completion date: January 2007

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to provide additional efficacy and safety data for a treatment strategy based on the combination valsartan with amlodipine in hypertensive patients previously treated with monotherapy and remaining uncontrolled. A naturalistic approach will be taken comparing two different doses, i.e. 160mg of valsartan with amlodipine 5mg and 10mg with possible addition of HCTZ

Recruitment information / eligibility

• Status: Completed
• Enrollment: 894
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Male or female patients =18 years of age

• Non-diabetic patients must have MSSBP of =140 mmHg and/or MSDBP =90 mmHg at Visits 1 and 2. Diabetic patients must have MSSBP =130 mmHg and/or MSDBP =80 mmHg at Visits 1 and 2

• Patients treated with monotherapy at a dose considered as adequate by the investigator for a minimum of two months prior to Visit 1

Exclusion criteria

• Known or suspected contraindications, including history of allergy to ARBs, CCB, thiazides or to drugs with similar chemical structure.

• MSSBP =180 mmHg and/or MSDBP =110 mmHg (MSSBP =160 mmHg and/or MSDBP =100 mmHg for diabetic patients) at any time between Visit 1 and Visit 2.

• Evidence of a secondary form of hypertension, to include coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, or pheochromocytoma.

• Known Keith-Wagener grade III or IV hypertensive retinopathy.

• Other exclusion criteria apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• valsartan

• hydrochlorothiazide

• amlodipine

Locations

Country	Name	City	State
Switzerland	Novartis Pharmaceuticals	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Allemann Y, Fraile B, Lambert M, Barbier M, Ferber P, Izzo JL Jr. Efficacy of the combination of amlodipine and valsartan in patients with hypertension uncontrolled with previous monotherapy: the Exforge in Failure after Single Therapy (EX-FAST) study. J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 16 weeks
Secondary	Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 8 weeks.
Secondary	Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 4, 12, and 16 weeks.
Secondary	Change from baseline diastolic and systolic blood pressure measurements after 4, 8, 12, and 16 weeks
Secondary	Diastolic blood pressure less than 90 mmHg in non-diabetic patients and diastolic blood pressure less than 80 mmHg in diabetic patients after 4, 8, 12, and 16 weeks

External Links

•   Results for CVAA489A2401 from the Novartis Clinical Trials website