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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Nifedipine (Adalat, BAYA1040) (Drug); Amlodipine (Norvasc) (Drug); Diovan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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

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

Primary outcome:

Mean treatment cost* for 16-week of double-blind treatment period

Proportion of participants** achieving target blood pressure at the end of double-blind treatment period

Secondary outcome:

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

Eligibility

Minimum age: 20 Years. Maximum age: 79 Years. Gender(s): Both.

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.

Locations and Contacts

Hiroshima 733-0011, Japan

Sapporo, Hokkaido 060-0003, Japan

Setagaya-ku, Tokyo 158-0097, Japan

Shinjuku-ku, Tokyo 163-6003, Japan

Additional Information

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Starting date: March 2004
Last updated: January 24, 2012

Page last updated: August 23, 2015

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