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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01241487
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arm: 1
• Duration (Months): 23
• Patients Per Site Per Month: 6.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Primary Hypertension	Drug: valsartan/amlodipine	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 valsartan/amlodipine	Drug: valsartan/amlodipine; 160/10 mg

Outcome Measures

Primary Outcome Measures

1. Hypertension in patients that will be controlled on each concentration and those that will switch to the higher concentration (160/10) [4 weeks]

Secondary Outcome Measures

1. 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]

2. Safety and Tolerability of the Trial Medication [8 weeks]

3. The incidence of Edema [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr Ahmed Anwar Clinic,	Cairo		Egypt

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01241487
• Other Study ID Numbers: CVAA489AEG02
• First Posted: Nov 16, 2010
• Last Update Posted: Feb 23, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by , ,: Hypertension, Valsartan/Amlodipine,
• Additional relevant MeSH terms: Hypertension; Essential Hypertension; Amlodipine; Valsartan

Study Results

No Results Posted as of Feb 23, 2017