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NCT01241487 Clinical Trial

A National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy

Primary Hypertension Clinical Trial

Official title:
An 8 Weeks Open Label National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01241487
Other study ID # CVAA489AEG02
Secondary ID
Status Completed
Phase Phase 4
First received November 15, 2010
Last updated February 21, 2017
Start date February 2009
Est. completion date January 2011

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in hypertensive patients uncontrolled by monotherapy.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Patient uncontrolled by mono-therapy for at least 8 weeks, having B.P.>/= 140/90 mmHg in non diabetics or >/= 130/80 mmHg in diabetics

Exclusion Criteria:

- Patient having B.P.>= 180/110 mmHg in non diabetics or >= 160/100 mmHg in diabetics

- Type 1 Diabetes or uncontrolled type 2 Diabetes.

- PCI in last 12 months.

- Concomitant unstable angina. Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• valsartan/amlodipine
160/10 mg

Locations
Country Name City State
Egypt Dr Ahmed Anwar Clinic, Cairo

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hypertension in patients that will be controlled on each concentration and those that will switch to the higher concentration (160/10) 4 weeks
Secondary Hypertension of patients that were previously controlled on (160/5) and those that were uncontrolled and switched to the higher concentration (160/10) after 4 weeks on (160/5) concentration. 8 weeks
Secondary Safety and Tolerability of the Trial Medication 8 weeks
Secondary The incidence of Edema 8 weeks
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