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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

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT01518855

First Posted

January 24, 2012

Last Updated

January 24, 2012

Sponsor

Bayer

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

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

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

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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