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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: November 15, 2010
Last updated: June 7, 2011
Last verified: June 2011
This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in hypertensive patients uncontrolled by monotherapy.

Condition Intervention Phase
Primary Hypertension
Drug: valsartan/amlodipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Hypertension in patients that will be controlled on each concentration and those that will switch to the higher concentration (160/10) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Safety and Tolerability of the Trial Medication [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • The incidence of Edema [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: February 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: valsartan/amlodipine
160/10 mg


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01241487

Dr Ahmed Anwar Clinic,
Cairo, Egypt
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01241487     History of Changes
Other Study ID Numbers: CVAA489AEG02 
Study First Received: November 15, 2010
Last Updated: June 7, 2011
Health Authority: Egypt: Ministry of Health and Population
Egypt: Ministry of Health, Drug Policy and Planning Center

Keywords provided by Novartis:
Hypertension, Valsartan/Amlodipine,

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Amlodipine, Valsartan Drug Combination
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 25, 2016