NCT01518855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
514

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
Last Updated

January 26, 2012

Status Verified

January 1, 2012

Enrollment Period

1.1 years

First QC Date

January 24, 2012

Last Update Submit

January 24, 2012

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • 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.

    16 weeks

  • 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)

    at week 16

Secondary Outcomes (5)

  • 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)

    16 weeks

  • The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) .

    baseline to week 16

  • Proportion of participants for each age group to target blood pressure level

    at week 16

  • Incidence of treatment-emergent drug-related adverse events

    16 weeks

  • Safety variables will be summarized using descriptive statistics based on adverse events collections

    16 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Adalat CR 20-40mg od + Diovan 40-80mg od

Drug: Nifedipine (Adalat, BAYA1040)Drug: Diovan

Arm 2

ACTIVE COMPARATOR

Norvasc 2.5-5mg od + Diovan 40-80mg od

Drug: Amlodipine (Norvasc)Drug: Diovan

Interventions

Nifedipine (Adalat, BAYA1040)DRUG
Arm 1
Amlodipine (Norvasc)DRUG
Arm 2
DiovanDRUG
Arm 1Arm 2

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Hiroshima, Hiroshima, 733-0011, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 060-0003, Japan

Location

Unknown Facility

Setagaya-ku, Tokyo, 158-0097, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, 163-6003, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

NifedipineAmlodipineValsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesAzolesValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 24, 2012

First Posted

January 26, 2012

Study Start

March 1, 2004

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

January 26, 2012

Record last verified: 2012-01

Locations

JP(4)