A Study to Evaluate the Combination of Valsartan + Amlodipine in Hypertensive Patients
An Multicenter Study to Evaluate the Efficacy and Tolerability of a 4-week Therapy With the Combination of Valsartan 160mg + Amlodipine 5mg in Hypertensive Patients Not Adequately Responding to 4-week Treatment With Amlo 5mg or Felodipine 5mg in Monotherapy
1 other identifier
interventional
224
2 countries
2
Brief Summary
The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with amlodipine or felodipine alone.
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 Aug 2006
Shorter than P25 for phase_3 hypertension
2 active sites
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
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 23, 2006
CompletedFirst Posted
Study publicly available on registry
October 25, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedNovember 18, 2016
November 1, 2016
6 months
October 23, 2006
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To investigate whether 4 weeks treatment with valsartan 160mg + amlo 5mg provide an add'l mean sitting systolic blood pressure reduction in patients not adequately responding to 4 weeks treatment with amlo 5mg or felodipine 5mg
Secondary Outcomes (3)
Mean sitting diastolic blood pressure (analogously & explorative)
Normalization (analogously & explorative)
Responder rate. (analogously & explorative)
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients (18 years)
- Patients with moderate essential hypertension (untreated must have MSSBP ≥160 and \<180 mmHg at Visit 1, treated must have MSSBP \<180 mmHg at Visit 1) (WHO grade II)
You may not qualify if:
- Severe hypertension(MSDBP ≥110 mmHg or MSSBP ≥ 180 mmHg)
- Pregnant or nursing women
- Treated hypertensive patients with controlled hypertension under current therapy (diastolic BP \< 90 mmHg and systolic BP \< 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 (2)
Unknown Facility
Investigative Centers, Germany
Novartis
Basel, Switzerland
Related Publications (1)
Brachmann J, Ansari A, Mahla G, Handrock R, Klebs S. Effective and safe reduction of blood pressure with the combination of amlodipine 5 mg and valsartan 160 mg in hypertensive patients not controlled by calcium channel blocker monotherapy. Adv Ther. 2008 May;25(5):399-411. doi: 10.1007/s12325-008-0054-6.
PMID: 18465097RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis +41 61 324 1111
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2006
First Posted
October 25, 2006
Study Start
August 1, 2006
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
November 18, 2016
Record last verified: 2016-11