Controlled Release Nifedipine and Valsartan Combination Therapy in Patients With Essential Hypertension - Full Text View

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.

Condition	Intervention	Phase
Hypertension	Drug: Nifedipine (Adalat, BAYA1040) Drug: Amlodipine (Norvasc) Drug: Diovan	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Clinical Effect and Cost Effectiveness of Ca Antagonist in Combination With AII Receptor Antagonist in Patient With Essential Hypertension (PMS Study)

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Nifedipine Amlodipine Valsartan

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Mean treatment cost* for 16-week of double-blind treatment period [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
* 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 ] [ Designated as safety issue: No ]
**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) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) . [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]
Proportion of participants for each age group to target blood pressure level [ Time Frame: at week 16 ] [ Designated as safety issue: No ]
Incidence of treatment-emergent drug-related adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Safety variables will be summarized using descriptive statistics based on adverse events collections [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]


Enrollment:	514
Study Start Date:	March 2004
Study Completion Date:	April 2005
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 Adalat CR 20-40mg od + Diovan 40-80mg od	Drug: Nifedipine (Adalat, BAYA1040) Drug: Diovan
Active Comparator: Arm 2 Norvasc 2.5-5mg od + Diovan 40-80mg od	Drug: Amlodipine (Norvasc) Drug: Diovan

Eligibility


Ages Eligible for Study:	20 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518855

Locations


Japan

Sapporo, Hokkaido, Japan, 060-0003

Setagaya-ku, Tokyo, Japan, 158-0097

Shinjuku-ku, Tokyo, Japan, 163-6003

Hiroshima, Japan, 733-0011

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

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No publications provided


Responsible Party:	Head Medical Development Japan, Bayer Yakuhin Ltd.
ClinicalTrials.gov Identifier:	NCT01518855 History of Changes
Other Study ID Numbers:	11518
Study First Received:	January 24, 2012
Last Updated:	January 24, 2012
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:


Hypertension Cardiovascular Diseases Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015