HypertensionPhase 2NCT00768560

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

A Phase 2 study testing Nifedipine (Adalat CR, BAYA1040) 80mg OD, Nifedipine (Adalat CR, BAYA1040) 40mg BID and Nifedipine (Adalat CR, BAYA1040) 40mg OD in people with Hypertension, run by Bayer at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Hypertension
What is being tested?: Nifedipine (Adalat CR, BAYA1040) 80mg OD, Nifedipine (Adalat CR, BAYA1040) 40mg BID and Nifedipine (Adalat CR, BAYA1040) 40mg OD
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 3 sitesJapan
Study dates: Jan 2008to May 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

Study site
Koshigaya, Saitama, 343-0827
Study site
Sendai, Miyagi, 982-0032
Study site
Suita, Osaka, 565-0853

Other trials in Japan

About this study

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

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).

Read the detailed description

Issues on safety are addressed in the Adverse Event section.

Conditions: Hypertension
Being tested: Nifedipine (Adalat CR, BAYA1040) 80mg OD, Nifedipine (Adalat CR, BAYA1040) 40mg BID, Nifedipine (Adalat CR, BAYA1040) 40mg OD
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nifedipine (Adalat CR, BAYA1040) 80mg ODDrug
Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
Nifedipine (Adalat CR, BAYA1040) 40mg BIDDrug
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) 40mg ODDrug
Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning

Study groups in NCT00768560
Study group	Role	What they receive
Nifedipine (Adalat CR, BAYA1040) 40 mg OD	Active comparator	Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning Receives: 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 Receives: 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 Receives: Drug: Nifedipine (Adalat CR, BAYA1040) 80mg OD

What is being measured

The primary outcome is the main question the study is designed to answer.

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])
Measured: Baseline and after 2 weeks treatment

Secondary outcomes (6)

Differences of Systolic Blood Pressure Profile
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)
Measured: Baseline and after 2 weeks treatment
Differences of Diastolic Blood Pressure Profile
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)
Measured: Baseline and after 2 weeks treatment
Target Blood Pressure Achievement in Elderly (≥65)
Elderly subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg
Measured: After 2 weeks treatment
Target Blood Pressure Achievement in Non-elderly (<65)
Non-elderly subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg
Measured: After 2 weeks treatment
Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder
Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg
Measured: After 2 weeks treatment
Target Blood Pressure Achievement in All Subjects
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.
Measured: After 2 weeks treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008May 2008

First posted8 Oct 2008 (estimated)
Study startJan 2008
Primary completionMay 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00768560
Sponsor's protocol ID: 13012
Status last verified: May 2015
First submitted: 7 Oct 2008
Last updated: 8 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of BAY A1040 CR Tablet on High Dose Administration in Patients With Essential Hypertension.
ClinicalTrials.gov ID: NCT00768560
Acronym / sponsor ID: 13012
Conditions: Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 8 Oct 2008 (estimated)
Results: Posted 2 Feb 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Issues on safety are addressed in the Adverse Event section.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Nifedipine (Adalat CR, BAYA1040) 40 mg OD	Active comparator	Drug: Nifedipine (Adalat CR, BAYA1040) 40mg ODNifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
Nifedipine (Adalat CR, BAYA1040) 40 mg BID	Experimental	Drug: Nifedipine (Adalat CR, BAYA1040) 40mg BIDNifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
Nifedipine (Adalat CR, BAYA1040) 80 mg OD	Experimental	Drug: Nifedipine (Adalat CR, BAYA1040) 80mg ODNifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nifedipine (Adalat CR, BAYA1040) 80mg ODNifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning	Drug	Nifedipine (Adalat CR, BAYA1040) 80 mg OD
Nifedipine (Adalat CR, BAYA1040) 40mg BIDNifedipine (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) 40 mg BID
Nifedipine (Adalat CR, BAYA1040) 40mg ODNifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning	Drug	Nifedipine (Adalat CR, BAYA1040) 40 mg OD

Primary outcome

Change of Sitting Blood Pressure
Time frame: Baseline and after 2 weeks treatment
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])

6 secondary outcomes

Differences of Systolic Blood Pressure Profile
Time frame: Baseline and after 2 weeks treatment
Differences of Diastolic Blood Pressure Profile
Time frame: Baseline and after 2 weeks treatment
Target Blood Pressure Achievement in Elderly (≥65)
Time frame: After 2 weeks treatment
Target Blood Pressure Achievement in Non-elderly (<65)
Time frame: After 2 weeks treatment
Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder
Time frame: After 2 weeks treatment
Target Blood Pressure Achievement in All Subjects
Time frame: After 2 weeks treatment

Results and safety

Results posted to the registry on 2 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each	5	5
Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each	6	5
Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each	6	6
Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each	6	6
Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each	6	6
Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each	6	6

Primary outcome: Change of Sitting Blood Pressure

Time frame: Baseline and after 2 weeks treatment. Least squares mean (Standard Error). Unit: mm Hg

Measure	Nifedipine (Adalat CR, BAYA1040) 40 mg OD n = 34	Nifedipine (Adalat CR, BAYA1040) 40 mg BID n = 34	Nifedipine (Adalat CR, BAYA1040) 80 mg OD n = 34
Systolic Blood Pressure	-10.19 (1.24)	-19.88 (1.24)	-10.13 (1.24)
Diastolic Blood Pressure	-4.30 (0.65)	-8.28 (0.65)	-4.98 (0.65)

Nifedipine (Adalat CR, BAYA1040) 40 mg OD vs Nifedipine (Adalat CR, BAYA1040) 40 mg BID: Mean Difference (Final Values): -9.69 (90% CI -12.62 to -6.77)
Nifedipine (Adalat CR, BAYA1040) 40 mg OD vs Nifedipine (Adalat CR, BAYA1040) 80 mg OD: Mean Difference (Final Values): 0.06 (90% CI -2.87 to 2.98)
Nifedipine (Adalat CR, BAYA1040) 40 mg BID vs Nifedipine (Adalat CR, BAYA1040) 80 mg OD: Mean Difference (Final Values): 9.75 (90% CI 6.83 to 12.67)

Population analysed: Per-protocol efficacy population: subjects valid for safety analysis who have no critical protocol deviation and have trough BP at the end of baseline treatment period and trough BP at the end of period 1 are considered valid for the analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nifedipine (Adalat CR, BAYA1040) 40 mg OD	0 of 35 (0%)	5 of 35 (14.3%)	Not reported
Nifedipine (Adalat CR, BAYA1040) 40 mg BID	0 of 34 (0%)	7 of 34 (20.6%)	Not reported
Nifedipine (Adalat CR, BAYA1040) 80 mg OD	0 of 34 (0%)	5 of 34 (14.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bayer Study Director study director

Bayer

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Sitting Blood Pressure (time frame: Baseline and after 2 weeks treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00768560.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.