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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01518855

First Posted: January 26, 2012

Last Update Posted: January 26, 2012

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.

Information provided by:

Bayer

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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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:

Drug Information available for: Nifedipine 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 ]
* 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)

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 ]
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 ]


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

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 79 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site


Responsible Party:	Head Medical Development Japan, Bayer Yakuhin Ltd.
ClinicalTrials.gov Identifier:	NCT01518855 History of Changes
Other Study ID Numbers:	11518
First Submitted:	January 24, 2012
First Posted:	January 26, 2012
Last Update Posted:	January 26, 2012
Last Verified:	January 2012

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Valsartan Nifedipine Antihypertensive Agents Calcium Channel Blockers	Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasodilator Agents Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists

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