check_circleStudy Completed

Hypertension

Bayer Identifier:

11518

ClinicalTrials.gov Identifier:

NCT01518855

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.

Key Participants Requirements

Sex

Both

Age

20 - 79 Years
  • 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
  • - 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.

Trial summary

Enrollment Goal
514
Trial Dates
March 2004 - April 2005
Phase
Phase 4
Could I Receive a placebo
No
Products
Adalat CC (Nifedipine, BAYA1040)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Shinjuku Oak Tower ClinicShinjuku-ku, 163-6003, Japan
Completed
Hiraoka Medical ClinicHiroshima, 733-0011, Japan
Completed
Tomita Medical Clinic Internal/Cardiovascular MedicineSapporo, 060-0003, Japan
Completed
Yoga Allergy ClinicSetagaya-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 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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 16
    enhanced_encryption
    Safety Issue:
    No

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 weeks
    enhanced_encryption
    Safety Issue:
    No
  • The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) .
    date_rangeTime Frame:
    baseline to week 16
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of participants for each age group to target blood pressure level
    date_rangeTime Frame:
    at week 16
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of treatment-emergent drug-related adverse events
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Safety variables will be summarized using descriptive statistics based on adverse events collections
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Clinical effect and cost effectiveness of Ca antagonist in combination with AII receptor antagonist in patient with essential hypertension (PMS study)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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