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Controlled Release Nifedipine and Valsartan Combination Therapy in Patients With Essential Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01518855
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : January 26, 2012
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date  ICMJE January 24, 2012
First Posted Date  ICMJE January 26, 2012
Last Update Posted Date January 26, 2012
Study Start Date  ICMJE March 2004
Actual Primary Completion Date April 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2012)
  • Mean treatment cost* for 16-week of double-blind treatment period [ Time Frame: 16 weeks ]
    * 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 [ Time Frame: at week 16 ]
    **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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2012)
  • 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 ]
  • The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) . [ Time Frame: baseline to week 16 ]
  • Proportion of participants for each age group to target blood pressure level [ Time Frame: at week 16 ]
  • Incidence of treatment-emergent drug-related adverse events [ Time Frame: 16 weeks ]
  • Safety variables will be summarized using descriptive statistics based on adverse events collections [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Controlled Release Nifedipine and Valsartan Combination Therapy in Patients With Essential Hypertension
Official Title  ICMJE Clinical Effect and Cost Effectiveness of Ca Antagonist in Combination With AII Receptor Antagonist in Patient With Essential Hypertension (PMS Study)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Nifedipine (Adalat, BAYA1040)
  • Drug: Amlodipine (Norvasc)
  • Drug: Diovan
Study Arms  ICMJE
  • Experimental: Arm 1
    Adalat CR 20-40mg od + Diovan 40-80mg od
    Interventions:
    • Drug: Nifedipine (Adalat, BAYA1040)
    • Drug: Diovan
  • Active Comparator: Arm 2
    Norvasc 2.5-5mg od + Diovan 40-80mg od
    Interventions:
    • Drug: Amlodipine (Norvasc)
    • Drug: Diovan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2012)
514
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2005
Actual Primary Completion Date April 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01518855
Other Study ID Numbers  ICMJE 11518
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Head Medical Development Japan, Bayer Yakuhin Ltd.
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP