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Trial record 18 of 99 for:    AMLODIPINE AND VALSARTAN

Efficacy and Safety of the Combination of Valsartan Plus Amlodipine in Hypertensive Patients Not Adequately Responding to the Combination Therapy With Ramipril Plus Felodipine

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ClinicalTrials.gov Identifier: NCT00367939
Recruitment Status : Completed
First Posted : August 24, 2006
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with ACE inhibitor plus calcium channel blocker

Condition or disease Intervention/treatment Phase
Hypertension Drug: valsartan + amlodipine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Multicenter Study to Evaluate the Efficacy and Safety of a 5 Week Therapy With the Combination of Valsartan 160 mg Plus Amlodipine 10 mg in Hypertensive Patients Not Adequately Responding to a 5 Week Therapy With Ramipril 5 mg and Felodipine 5 mg
Study Start Date : December 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. To investigate whether 5 weeks of treatment with valsartan 160mg + amlodipine 10mg provide add'l mean sitting systolic BP reduction in patients not adequately responding to 5 weeks of treatment with ramipril + felodipine--i.e., mean systolic BP

Secondary Outcome Measures :
  1. To evaluate the effects of valsartan 160 mg plus amlodipine 10 mg on mean sitting diastolic BP, normalization and responder rate.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Male or female patients (18 years or older)
  • Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives).
  • Patients with moderate essential hypertension (WHO II)

Exclusion Criteria:

  • Severe hypertension
  • Pregnant or nursing women
  • Treated hypertensive patients with controlled hypertension under current therapy (MSDBP < 90 mmHg and MSSBP < 140 mmHg)
  • A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
  • Other protocol-defined exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367939


Locations
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Germany
Investigative Centers, Germany
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Pharma Ag Novartis Pharmaceuticals

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00367939     History of Changes
Other Study ID Numbers: CVAA489ADE01
First Posted: August 24, 2006    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Keywords provided by Novartis:
Hypertension
Additional relevant MeSH terms:
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Amlodipine
Valsartan
Hypertension
Vascular Diseases
Cardiovascular Diseases
Felodipine
Ramipril
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents