Efficacy and Safety of the Combination of Valsartan Plus Amlodipine in Hypertensive Patients Not Adequately Responding to the Combination Therapy With Ramipril Plus Felodipine
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
1 other identifier
interventional
132
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hypertension
Started Dec 2005
Shorter than P25 for phase_3 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 22, 2006
CompletedFirst Posted
Study publicly available on registry
August 24, 2006
CompletedMay 18, 2017
May 1, 2017
7 months
August 22, 2006
May 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (1)
To evaluate the effects of valsartan 160 mg plus amlodipine 10 mg on mean sitting diastolic BP, normalization and responder rate.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Unknown Facility
Investigative Centers, Germany
Related Publications (1)
Trenkwalder P, Schaetzl R, Borbas E, Handrock R, Klebs S. Combination of amlodipine 10 mg and valsartan 160 mg lowers blood pressure in patients with hypertension not controlled by an ACE inhibitor/CCB combination. Blood Press Suppl. 2008 Dec;2:13-21. doi: 10.1080/08038020802488855.
PMID: 19205092DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharma Ag
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2006
First Posted
August 24, 2006
Study Start
December 1, 2005
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
May 18, 2017
Record last verified: 2017-05