Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study - Full Text View

Purpose

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).

Condition	Intervention	Phase
Hypertension	Drug: Nifedipine (Adalat CR, BAYA1040) 80mg OD Drug: Nifedipine (Adalat CR, BAYA1040) 40mg BID Drug: Nifedipine (Adalat CR, BAYA1040) 40mg OD	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Evaluation of the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of BAY A1040 CR Tablet on High Dose Administration in Patients With Essential Hypertension.

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Nifedipine

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Change of Sitting Blood Pressure [ Time Frame: Baseline and after 2 weeks treatment ] [ Designated as safety issue: No ]
Changes of sitting SBP and DBP (trough values) from baseline (ie [trough BP at the end of each period during the double-blind treatment period] minus [trough BP at the end of the baseline treatment period])

Secondary Outcome Measures:

Differences of Systolic Blood Pressure Profile [ Time Frame: Baseline and after 2 weeks treatment ] [ Designated as safety issue: No ]
Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)
Differences of Diastolic Blood Pressure Profile [ Time Frame: Baseline and after 2 weeks treatment ] [ Designated as safety issue: No ]
Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)
Target Blood Pressure Achievement in Elderly (≥65) [ Time Frame: After 2 weeks treatment ] [ Designated as safety issue: No ]
Elderly subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg
Target Blood Pressure Achievement in Non-elderly (<65) [ Time Frame: After 2 weeks treatment ] [ Designated as safety issue: No ]
Non-elderly subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg
Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder [ Time Frame: After 2 weeks treatment ] [ Designated as safety issue: No ]
Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg
Target Blood Pressure Achievement in All Subjects [ Time Frame: After 2 weeks treatment ] [ Designated as safety issue: No ]
Subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg. Subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg. Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg.

Enrollment:	35
Study Start Date:	January 2008
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Nifedipine (Adalat CR, BAYA1040) 40 mg OD Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning	Drug: Nifedipine (Adalat CR, BAYA1040) 40mg OD Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
Experimental: Nifedipine (Adalat CR, BAYA1040) 40 mg BID Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening	Drug: Nifedipine (Adalat CR, BAYA1040) 40mg BID Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
Experimental: Nifedipine (Adalat CR, BAYA1040) 80 mg OD Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning	Drug: Nifedipine (Adalat CR, BAYA1040) 80mg OD Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning

Detailed Description:

Issues on safety are addressed in the Adverse Event section.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768560

Locations

Japan

Sendai, Miyagi, Japan, 982-0032

Suita, Osaka, Japan, 565-0853

Koshigaya, Saitama, Japan, 343-0827

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

No publications provided

Responsible Party:	Head Clinical Pharmacology, Bayer Yakuhin, Ltd.
ClinicalTrials.gov Identifier:	NCT00768560 History of Changes
Other Study ID Numbers:	13012
Study First Received:	October 7, 2008
Results First Received:	September 28, 2009
Last Updated:	June 1, 2012
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Nifedipine
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2013