HypertensionPhase 1NCT02348658

A Phase 1 Food Effect Study of TAK-536TCH Final Formulation Tablet

A Phase 1 study testing TAK-536TCH in people with Hypertension, run by Takeda at 1 site in Japan.

Completed

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

Trial summary

This is a phase 1, randomized, open-label, crossover study to evaluate the food-effect of single oral dose of TAK-536TCH final formulation tablet in healthy adult male participants. Read more about this study

Who is it for?: Ages 20 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Hypertension
What is being tested?: TAK-536TCH
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteJapan
Study dates: Jan 2015to Mar 2015
Phase: Phase 1
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 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

1. In the opinion of the investigator and subinvestigator, the participant is capable of understanding and complying with protocol requirements.
2. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
3. The participant is a healthy Japanese adult male. 4. The participant is aged 20 to 35 years, inclusive at the time of informed consent.
5. The participant weighs at least 50.0 kg and has a body mass index (BMI) from 18.5 to 25.0 kilograms per square meter (kg/m^2), inclusive at Screening.

Who cannot join

Participant has systolic blood pressure less-than (<) 90 millimeters of mercury (mmHg) at Screening.
Participant has suspected hypotension and associated physical findings, such as dizziness postural, facial pallor, or cold sweats based on evaluation/physical examination at Screening, on Day -1 of Period 1, or up to administration on the Period 1.
The participant has received any study drug within 16 weeks (that is [i.e.], 112 days) prior to study drug administration of Period 1.
The participant has received TAK-491*, TAK-536, amlodipine, or hydrochlorothiazide in a previous clinical study or as a therapeutic agent.
The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, or endocrine disease, or other abnormality (other than the disease studied), which could impact the ability of the participant to participate or potentially confound the study results.
Participant has a known hypersensitivity to drugs.

Show all 20Show fewer

Participant has a positive urine drug result for drugs of abuse at Screening.
Participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the Screening visit or was unwilling to agree to abstain from alcohol and drugs throughout the study.
Participant required any prohibited concomitant drugs, vitamins, or food products listed in the prohibited concomitant drugs and foods table.
Participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention [e.g., cholecystectomy]).
Participant has a history of cancer.
Participant has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at Screening.
Participant has poor peripheral venous access.
Participant has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to study drug administration in Period 1.
Participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to study drug administration in Period 1.
Participant has undergone blood component collection within 2 weeks (14 days) prior to study drug administration in Period 1.
Participant has a hemoglobin value of less than 12.5 g/dL in laboratory testing at Screening or prior to study drug administration in Period 1.
Participant has a clinically significant ECG abnormality at Screening or prior to study drug administration in Period 1.
Participant has abnormal laboratory values at Screening or prior to study drug administration of Period 1 that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is >1.5-fold the upper limits of normal range.
Participant who, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Fukuoka, Fukuoka

Other trials in Japan

About this study

Official title: A Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Food-Effect of Single Oral Dose of TAK-536TCH Final Formulation Tablet in Healthy Adult Male Subjects

This is a phase 1, randomized, open-label, crossover study to evaluate the food-effect of single oral dose of TAK-536TCH final formulation tablet in healthy adult male participants.

Read the detailed description

The purpose of this study is to evaluate the food effect on the pharmacokinetics and safety of a single oral dose of TAK-536TCH under fasted and fed conditions in the morning in healthy adult male participants.

Conditions: Hypertension
Being tested: TAK-536TCH
Keywords: Pharmacological therapy
Medical subject headings: Hypertension

What participants receive

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

TAK-536TCHDrug
TAK-536TCH tablets

Study groups in NCT02348658
Study group	Role	What they receive
Fasted dosing followed by fed dosing	Other	Dosing in the fasted state followed by fed dosing Receives: Drug: TAK-536TCH
Fed dosing followed by fasted dosing	Other	Dosing in the fed state followed by fasted dosing Receives: Drug: TAK-536TCH

What is being measured

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

Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ)
Measured: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
Cmax: Maximum Plasma Concentration for Amlodipine Besilate (AML)
Measured: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
AUC(0-48) is a measure of the area under the plasma concentration time-curve from time 0 to 48 hours postdose.
Measured: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose in Each Period for AML
AUC(0-120) is a measure of the area under the plasma concentration time-curve from time 0 to 120 hours postdose.
Measured: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
Measured: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for AML
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
Measured: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Measured: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for AML
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Measured: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
Urinary Excretion Ratio of TAK-536, Its Metabolites (M-I and M-II) and HCTZ
Urinary excretion ratio (percent [%] of dose) of TAK-536, its metabolite M-I, M-II and HCTZ in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.
Measured: Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period
Urinary Excretion Ratio of AML
Urinary excretion ratio (% of dose) of AML in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.
Measured: Day 1: predose and at multiple time-points (up to 120 hours) postdose in each period

Secondary outcomes (5)

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Measured: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Number of Participants With TEAEs Related to Vital Signs
Measured: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Number of Participants With TEAEs Related to Body Weight
Measured: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values
Measured: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Number of Participants With Clinical Significant Findings in Electrocardiograms After Study Drug Administration
Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measurement.
Measured: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )

Timeline

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

Jan 2015Mar 2015

First posted28 Jan 2015 (estimated)
Study startJan 2015
Primary completionMar 2015
Study completionMar 2015

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 TakedaThe 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02348658
Sponsor's protocol ID: TAK-536TCH/CPH-004
Other IDs: U1111-1165-5595, JapicCTI-152777
Status last verified: Mar 2016
First submitted: 15 Jan 2015
Last updated: 26 Apr 2016
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 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Food-Effect of Single Oral Dose of TAK-536TCH Final Formulation Tablet in Healthy Adult Male Subjects
ClinicalTrials.gov ID: NCT02348658
Acronym / sponsor ID: TAK-536TCH/CPH-004
Conditions: Hypertension
Keywords: Pharmacological therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 28 Jan 2015 (estimated)
Results: Posted 26 Apr 2016

Clinical summary

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

This is a phase 1, randomized, open-label, crossover study to evaluate the food-effect of single oral dose of TAK-536TCH final formulation tablet in healthy adult male participants.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fasted dosing followed by fed dosing	Other	Drug: TAK-536TCHDosing in the fasted state followed by fed dosing
Fed dosing followed by fasted dosing	Other	Drug: TAK-536TCHDosing in the fed state followed by fasted dosing

Who may qualify

Ages: 20 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

1. In the opinion of the investigator and subinvestigator, the participant is capable of understanding and complying with protocol requirements.
2. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
3. The participant is a healthy Japanese adult male. 4. The participant is aged 20 to 35 years, inclusive at the time of informed consent.
5. The participant weighs at least 50.0 kg and has a body mass index (BMI) from 18.5 to 25.0 kilograms per square meter (kg/m^2), inclusive at Screening.

Key exclusion criteria (20 listed)

Participant has systolic blood pressure less-than (<) 90 millimeters of mercury (mmHg) at Screening.
Participant has suspected hypotension and associated physical findings, such as dizziness postural, facial pallor, or cold sweats based on evaluation/physical examination at Screening, on Day -1 of Period 1, or up to administration on the Period 1.
The participant has received any study drug within 16 weeks (that is [i.e.], 112 days) prior to study drug administration of Period 1.
The participant has received TAK-491*, TAK-536, amlodipine, or hydrochlorothiazide in a previous clinical study or as a therapeutic agent.
The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, or endocrine disease, or other abnormality (other than the disease studied), which could impact the ability of the participant to participate or potentially confound the study results.

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
TAK-536TCHTAK-536TCH tablets	Drug	Fasted dosing followed by fed dosing, Fed dosing followed by fasted dosing

Primary outcome

Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ)
Time frame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
Cmax: Maximum Plasma Concentration for Amlodipine Besilate (AML)
Time frame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
Time frame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
AUC(0-48) is a measure of the area under the plasma concentration time-curve from time 0 to 48 hours postdose.
AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose in Each Period for AML
Time frame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
AUC(0-120) is a measure of the area under the plasma concentration time-curve from time 0 to 120 hours postdose.
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
Time frame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for AML
Time frame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
Time frame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for AML
Time frame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Urinary Excretion Ratio of TAK-536, Its Metabolites (M-I and M-II) and HCTZ
Time frame: Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period
Urinary excretion ratio (percent [%] of dose) of TAK-536, its metabolite M-I, M-II and HCTZ in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.
Urinary Excretion Ratio of AML
Time frame: Day 1: predose and at multiple time-points (up to 120 hours) postdose in each period
Urinary excretion ratio (% of dose) of AML in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.

5 secondary outcomes

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Number of Participants With TEAEs Related to Vital Signs
Time frame: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Number of Participants With TEAEs Related to Body Weight
Time frame: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values
Time frame: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Number of Participants With Clinical Significant Findings in Electrocardiograms After Study Drug Administration
Time frame: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )

Results and safety

Results posted to the registry on 26 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAK-536TCH Fasted + TAK-536TCH Fed	6	6
TAK-536TCH Fed + TAK-536TCH Fasted	6	6

Primary outcome: Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ)

Time frame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period. Mean (Standard Deviation). Unit: nanogram per milliliter (ng/mL)

Measure	TAK-536TCH Fasted n = 12	TAK-536TCH Fed n = 12
TAK-536	1912.0 (253.39)	1783.7 (318.16)
M-I	448.3 (143.36)	455.3 (131.68)
M-II	453.5 (109.75)	451.9 (101.18)
HCTZ	119.4 (30.481)	101.6 (14.700)

Population analysed: Pharmacokinetic (PK) analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.

Primary outcome: Cmax: Maximum Plasma Concentration for Amlodipine Besilate (AML)

Time frame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period. Mean (Standard Deviation). Unit: ng/mL

Measure	TAK-536TCH Fasted n = 12	TAK-536TCH Fed n = 12
Value	3.752 (0.5124)	3.668 (0.6468)

Population analysed: PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.

Primary outcome: AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ

Time frame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period. Mean (Standard Deviation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	TAK-536TCH Fasted n = 12	TAK-536TCH Fed n = 12
TAK-536	14599.8 (2254.31)	13279.4 (2889.22)
M-I	3215.8 (698.75)	2693.8 (706.41)
M-II	9093.3 (1711.69)	8990.8 (2310.99)
HCTZ	670.8 (75.912)	595.2 (68.915)

Primary outcome: AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose in Each Period for AML

Time frame: Day 1: predose and at multiple time points (up to 120 hours) postdose in each period. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	TAK-536TCH Fasted n = 12	TAK-536TCH Fed n = 12
Value	119.370 (27.7395)	125.749 (26.9893)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days for a serious adverse event after the last dose of study drug (14 days after Day 1 of Period 2).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-536TCH Fasted	0 of 12 (0%)	1 of 12 (8.3%)	Not reported
TAK-536TCH Fed	0 of 12 (0%)	1 of 12 (8.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
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.

Study Manager study chair

Takeda

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-536TCH in people with Hypertension, run by Takeda at 1 site in Japan.

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 4 inclusion and 20 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 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 26 Apr 2016). 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?

Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ) (time frame: Day 1: predose and at multiple time points (up to 48 hours) postdose in each period). The study lists 10 primary outcomes in all. 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 NCT02348658.

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 26 Apr 2016.