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Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study

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 CR, BAYA1040) 80mg OD (Drug); Nifedipine (Adalat CR, BAYA1040) 40mg BID (Drug); Nifedipine (Adalat CR, BAYA1040) 40mg OD (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bayer

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

Summary

This is a multi-center, randomized, double-blind, 6 x 3 cross-over study. All patients who meet the entry criteria will be required to stop taking any other anti-hypertensive agents than Adalat CR (controlled release), if taken, before starting 4 weeks (7days) open-label Adalat CR 40 mg once daily (OD) treatment phase (baseline treatment period). Of them, those who are confirmed with their eligibility as subjects for the present study at the end of the baseline treatment period will be randomly allocated to one of the 6 treatment sequences on the basis of a computer-generated randomization list. Subsequently, BAY A1040 CR tablet 40 mg OD, 40 mg twice daily (BID) or 80 mg OD will be administered to a total of 6 weeks, 2 weeks per each treatment period (Period 1-3) under double-blind conditions using BAY A1040 CR tablet 40 mg and its placebo as follows (Double-blind treatment period).

Clinical Details

Official title: Evaluation of the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of BAY A1040 CR Tablet on High Dose Administration in Patients With Essential Hypertension.

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

Primary outcome: Change of Sitting Blood Pressure

Secondary outcome:

Differences of Systolic Blood Pressure Profile

Differences of Diastolic Blood Pressure Profile

Target Blood Pressure Achievement in Elderly (≥65)

Target Blood Pressure Achievement in Non-elderly (<65)

Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder

Target Blood Pressure Achievement in All Subjects

Detailed description: Issues on safety are addressed in the Adverse Event section.

Eligibility

Minimum age: 20 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female

- 20 years or older and less than 75 years

- Outpatient

- Untreated or treated patients with antihypertensive agents whose blood pressure (BP)

in sitting position at entry (Visit 1) is as follows.

- Untreated patients: systolic blood pressure (SBP) >= 160mmHg or diastolic blood

pressure (DBP) >= 100mmHg

- Treated patients: SBP >= 140mmHg or DBP >= 90mmHg (at trough)

Exclusion Criteria:

- Patients whose BP during baseline treatment period is: SBP>=200mmHg or DBP>=120mmHg.

- Patients with secondary hypertension or hypertensive emergency.

- Patients with cardiovascular or cerebrovascular ischemic event (stroke, transient

ischemic attack (TIA), myocardial infarction or unstable angina), or with history of these within 6 months prior to the study.

- Patients with intracranial or subarachnoid hemorrhage, or with history of these

within 6 months prior to the study.

- Patients with server hematopoietic dysfunction (acute/chronic leukemia, myeloma,

malignant lymphoma, myelodysplastic syndrome, aplastic anemia), or with history of these.

Locations and Contacts

Sendai, Miyagi 982-0032, Japan

Suita, Osaka 565-0853, Japan

Koshigaya, Saitama 343-0827, Japan

Additional Information

Click here and search for drug information provided by the FDA.

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

Starting date: January 2008
Last updated: May 13, 2015

Page last updated: August 23, 2015

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