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Completed

NCT Number: NCT01241487

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

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Key information

Conditions

Primary Hypertension Cardiovascular Diseases Essential Hypertension Hypertension Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr Ahmed Anwar Clinic,

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valsartan/amlodipine

Drug

160/10 mg

Primary outcomes

  1. 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

Secondary outcomes

  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.

    Time frame: 8 weeks

  2. Safety and Tolerability of the Trial Medication

    Time frame: 8 weeks

  3. The incidence of Edema

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 16, 2010
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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