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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: Nifedipine (Adalat, BAYA1040); Drug: Amlodipine (Norvasc); Drug: Diovan	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	514 participants
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)
Study Start Date :	March 2004
Actual Primary Completion Date :	April 2005
Actual Study Completion Date :	April 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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 :

1. 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 ]
2. The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) . [ Time Frame: baseline to week 16 ]
3. Proportion of participants for each age group to target blood pressure level [ Time Frame: at week 16 ]
4. Incidence of treatment-emergent drug-related adverse events [ Time Frame: 16 weeks ]
5. Safety variables will be summarized using descriptive statistics based on adverse events collections [ Time Frame: 16 weeks ]

Eligibility Criteria

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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Responsible Party:	Head Medical Development Japan, Bayer Yakuhin Ltd.
ClinicalTrials.gov Identifier:	NCT01518855 History of Changes
Other Study ID Numbers:	11518
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