Controlled Release Nifedipine and Valsartan Combination Therapy in Patients With Essential Hypertension
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Nifedipine (Adalat, BAYA1040)
Amlodipine (Norvasc)
Diovan
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
Untreated patients or patients with previous treatment by antihypertensive agents whose blood pressure at sitting position at the time of the entry (Visit 1) is:
- SBP>/=160mmHg or DBP>/=100mmHg for untreated patients (SBP Systolic blood pressure, DBP Diastolic blood pressure)
- SBP>/=150mmHg or DBP>/=95mmHg for patients with previous treatment by antihypertensive agents
Exclusion Criteria:
- Patients whose blood pressure on either day of Visit 1 or 2 is: SBP > 200mmHg or DBP > 120mmHg.
- Patients with secondary hypertension or hypertensive emergency such as malignant hypertension.
- Patients with a history of cardiovascular or cerebrovascular ischemic event (stroke, transient ischemic attack, myocardial infarction or unstable angina) within six months prior to the study.
- Patients with a history of intracranial or subarachnoid hemorrhage within six months prior to the study.
- Patients with uncontrolled diabetes (HbA1c >/=8%)
- Patients with bradycardia or tachycardia (<50 bpm, >/=100 bpm), arrhythmia such as atrioventricular block (second and third degree), sinoatrial block or atrial fibrillation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Adalat CR 20-40mg od + Diovan 40-80mg od
Norvasc 2.5-5mg od + Diovan 40-80mg od
Outcomes
Primary Outcome Measures
Mean treatment cost* for 16-week of double-blind treatment period
* Including treatment cost for the drug related AEs. The sponsor will calculate the cost based on the tariff of health insurance scores.
Proportion of participants** achieving target blood pressure at the end of double-blind treatment period
**For subjects aged under 60 years: SBP<130mmHg and DBP<85mmHg, for subjects aged 60 years or over: SBP<140mmHg and DBP<90mmHg (SBP Systolic blood pressure, DBP Diastolic blood pressure)
Secondary Outcome Measures
Treatment cost per subject to achieve the target blood pressure (Total costs for the double-blind treatment period / Number of patients who achieve the target blood pressure at the end of double-blind treatment period)
The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) .
Proportion of participants for each age group to target blood pressure level
Incidence of treatment-emergent drug-related adverse events
Safety variables will be summarized using descriptive statistics based on adverse events collections
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01518855
Brief Title
Controlled Release Nifedipine and Valsartan Combination Therapy in Patients With Essential Hypertension
Official Title
Clinical Effect and Cost Effectiveness of Ca Antagonist in Combination With AII Receptor Antagonist in Patient With Essential Hypertension (PMS Study)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to investigate incremental cost effectiveness of Nifedipine CR and Amlodipine in combination therapy with Valsartan for the treatment of essential hypertensive patients.
To investigate incremental cost effectiveness, primary variables are mean treatment cost and achievement rate to target blood pressure level at the end of double-blind treatment period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
514 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Adalat CR 20-40mg od + Diovan 40-80mg od
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Norvasc 2.5-5mg od + Diovan 40-80mg od
Intervention Type
Drug
Intervention Name(s)
Nifedipine (Adalat, BAYA1040)
Intervention Type
Drug
Intervention Name(s)
Amlodipine (Norvasc)
Intervention Type
Drug
Intervention Name(s)
Diovan
Primary Outcome Measure Information:
Title
Mean treatment cost* for 16-week of double-blind treatment period
Description
* Including treatment cost for the drug related AEs. The sponsor will calculate the cost based on the tariff of health insurance scores.
Time Frame
16 weeks
Title
Proportion of participants** achieving target blood pressure at the end of double-blind treatment period
Description
**For subjects aged under 60 years: SBP<130mmHg and DBP<85mmHg, for subjects aged 60 years or over: SBP<140mmHg and DBP<90mmHg (SBP Systolic blood pressure, DBP Diastolic blood pressure)
Time Frame
at week 16
Secondary Outcome Measure Information:
Title
Treatment cost per subject to achieve the target blood pressure (Total costs for the double-blind treatment period / Number of patients who achieve the target blood pressure at the end of double-blind treatment period)
Time Frame
16 weeks
Title
The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) .
Time Frame
baseline to week 16
Title
Proportion of participants for each age group to target blood pressure level
Time Frame
at week 16
Title
Incidence of treatment-emergent drug-related adverse events
Time Frame
16 weeks
Title
Safety variables will be summarized using descriptive statistics based on adverse events collections
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Untreated patients or patients with previous treatment by antihypertensive agents whose blood pressure at sitting position at the time of the entry (Visit 1) is:
SBP>/=160mmHg or DBP>/=100mmHg for untreated patients (SBP Systolic blood pressure, DBP Diastolic blood pressure)
SBP>/=150mmHg or DBP>/=95mmHg for patients with previous treatment by antihypertensive agents
Exclusion Criteria:
Patients whose blood pressure on either day of Visit 1 or 2 is: SBP > 200mmHg or DBP > 120mmHg.
Patients with secondary hypertension or hypertensive emergency such as malignant hypertension.
Patients with a history of cardiovascular or cerebrovascular ischemic event (stroke, transient ischemic attack, myocardial infarction or unstable angina) within six months prior to the study.
Patients with a history of intracranial or subarachnoid hemorrhage within six months prior to the study.
Patients with uncontrolled diabetes (HbA1c >/=8%)
Patients with bradycardia or tachycardia (<50 bpm, >/=100 bpm), arrhythmia such as atrioventricular block (second and third degree), sinoatrial block or atrial fibrillation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0003
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
158-0097
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
163-6003
Country
Japan
City
Hiroshima
ZIP/Postal Code
733-0011
Country
Japan
12. IPD Sharing Statement
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Controlled Release Nifedipine and Valsartan Combination Therapy in Patients With Essential Hypertension
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