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

NCT00768560 | Completed Phase 2 Results

• 1 other identifier: 13012
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change of Sitting Blood Pressure

  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 \[trough BP at the end of the baseline treatment period\])

  Baseline and after 2 weeks treatment

Secondary Outcomes (6)

• Differences of Systolic Blood Pressure Profile

  Baseline and after 2 weeks treatment

• Differences of Diastolic Blood Pressure Profile

  Baseline and after 2 weeks treatment

• Target Blood Pressure Achievement in Elderly (≥65)

  After 2 weeks treatment

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

  After 2 weeks treatment

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

  After 2 weeks treatment

Study Arms (3)

Nifedipine (Adalat CR, BAYA1040) 40 mg OD

ACTIVE COMPARATOR

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 mg BID

EXPERIMENTAL

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) 80 mg OD

EXPERIMENTAL

Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning

Drug: Nifedipine (Adalat CR, BAYA1040) 80mg OD

Interventions

Nifedipine (Adalat CR, BAYA1040) 80mg OD DRUG

Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning

Nifedipine (Adalat CR, BAYA1040) 80 mg OD

Nifedipine (Adalat CR, BAYA1040) 40mg BID DRUG

Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening

Nifedipine (Adalat CR, BAYA1040) 40 mg BID

Nifedipine (Adalat CR, BAYA1040) 40mg OD DRUG

Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning

Nifedipine (Adalat CR, BAYA1040) 40 mg OD

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (3)

Unknown Facility

Sendai, Miyagi, 982-0032, Japan

Location

Unknown Facility

Suita, Osaka, 565-0853, Japan

Location

Unknown Facility

Koshigaya, Saitama, 343-0827, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

Nifedipine; BID protein, human

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 8, 2015
• Results First Posted: February 2, 2010

Record last verified: 2015-05

Locations

JP (3)