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

Hypertension Clinical Trial

Official title:

Clinical Effect and Cost Effectiveness of Ca Antagonist in Combination With AII Receptor Antagonist in Patient With Essential Hypertension (PMS Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518855
• Other study ID #: 11518
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2012
• Last updated: January 24, 2012
• Start date: March 2004
• Est. completion date: April 2005

Study information

• Verified date: January 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 514
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Nifedipine (Adalat, BAYA1040)

• Amlodipine (Norvasc)

• Diovan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) .		baseline to week 16	No
Secondary	Proportion of participants for each age group to target blood pressure level		at week 16	No
Secondary	Incidence of treatment-emergent drug-related adverse events		16 weeks	Yes
Secondary	Safety variables will be summarized using descriptive statistics based on adverse events collections		16 weeks	Yes

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