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
Verified date | February 2017 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in hypertensive patients uncontrolled by monotherapy.
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Dr Ahmed Anwar Clinic, | Cairo |
Lead Sponsor | Collaborator |
---|---|
Novartis |
Egypt,
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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