check_circleStudy Completed
Hypertension
Bayer Identifier:
11518
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Controlled Release Nifedipine and Valsartan Combination Therapy in Patients with Essential Hypertension
Trial purpose
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.
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.
Key Participants Requirements
Sex
BothAge
20 - 79 YearsTrial summary
Enrollment Goal
514Trial Dates
March 2004 - April 2005Phase
Phase 4Could I Receive a placebo
NoProducts
Adalat CC (Nifedipine, BAYA1040)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Shinjuku Oak Tower Clinic | Shinjuku-ku, 163-6003, Japan |
Completed | Hiraoka Medical Clinic | Hiroshima, 733-0011, Japan |
Completed | Tomita Medical Clinic Internal/Cardiovascular Medicine | Sapporo, 060-0003, Japan |
Completed | Yoga Allergy Clinic | Setagaya-ku, 158-0097, Japan |
Primary Outcome
- 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.date_rangeTime Frame:16 weeksenhanced_encryptionNoSafety Issue:
- 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)date_rangeTime Frame:at week 16enhanced_encryptionNoSafety Issue:
Secondary Outcome
- 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)date_rangeTime Frame:16 weeksenhanced_encryptionNoSafety Issue:
- The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) .date_rangeTime Frame:baseline to week 16enhanced_encryptionNoSafety Issue:
- Proportion of participants for each age group to target blood pressure leveldate_rangeTime Frame:at week 16enhanced_encryptionNoSafety Issue:
- Incidence of treatment-emergent drug-related adverse eventsdate_rangeTime Frame:16 weeksenhanced_encryptionYesSafety Issue:
- Safety variables will be summarized using descriptive statistics based on adverse events collectionsdate_rangeTime Frame:16 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2