HypertensionPhase 2NCT01614366

DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension

A Phase 2 study testing AM 5 + DM 0, AM 5 + DM 2.5 and AM 5 + DM 7.5 in people with Hypertension, run by TSH Biopharm Corporation Limited at 8 sites in Taiwan.

Completed

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

Official record

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Trial summary

The purpose of this study is to compare the different dose of DMTA07 (DM) combine with amlodipine in the treatment of mild to moderate essential hypertension, and to define the optimized dose of DM in the combination therapy. Read more about this study

Who is it for?: Ages 50 to 75 years
Conditions the study is for: Hypertension
What is being tested?: AM 5 + DM 0, AM 5 + DM 2.5 and AM 5 + DM 7.5
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 111 participants
Where: 8 sitesTaiwan
Study dates: Jul 2012to May 2014
Phase: Phase 2
Are there results?: None posted in the registry

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

Who may be able to join

Male or female patient aged between 50 to 75 years old (both included);
Patient with mild to moderate essential hypertension at enrollment, which defined as the following:
Patient must have mean sitting SBP ≥140 and <180 mmHg or mean sitting DBP ≥90 and <110 mmHg at enrollment;
Patient with normal serum potassium;
Patient or his/her legally acceptance representative has signed the written informed consent form.

Who cannot join

Patient with severe hypertension (mean sitting DBP ≥ 110 mmHg or mean sitting SBP ≥ 180 mmHg);
Patient with secondary hypertension, such as coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc;
Patient is under treatment with beta-blocker prior to enrollment;
A definite diagnosis or unstable of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, arrhythmia and heart failure within 3 months before signing the written informed consent form;
Patient with concomitant endocrine diseases or type 1 Diabetes Mellitus;
Patient with type 2 Diabetes Mellitus with poor glucose control (glycosylated hemoglobin > 9% or fasting blood sugar > 250 mg/dL at enrollment) or under insulin treatment;

Show all 18Show fewer

Patient with clinically unstable disease such as known collagen or auto-immune disease or other malignant disease requiring current medication;
Patient with bilateral renal artery stenosis, solitary kidney or post renal transplant;
Patient with clinically relevant hematological disease;
Hepatic or renal dysfunction as defined by the following parameters:
ALT or AST > 2 times upper limit of normal,
Total bilirubin > 2 times upper limit of normal,
Serum creatinine >2.0 mg/dl;
Female patient who is pregnant or lactating;
Patient with substance abuse (including alcohol) history for the past two years;
Known or suspected contraindications, including allergy to DMTA07 or calcium channel blockers;
Patient received other investigational drug or device within 30 days before signing the written informed consent form;
Patient with any other serious disease considered by the investigator(s) not in the condition to enter the trial.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Taiwan8 sites

E-DA Hospital
Kaohsiung City, 824
Taichung Veterans General Hospital
Taichung, 40705
National Taiwan University Hospital
Taipei, 100
Mackay Memorial Hospital
Taipei, 104
Cheng Hsin General Hospital
Taipei, 112
Taipei Veterans General Hospital
Taipei, 112
Tri-Service General Hospital
Taipei, 114
Chang Gung Memorial Hospital
Taoyuan County, 333

Other trials in Taiwan

About this study

Official title: A Phase II Study to Explore the Effect of Different Dose of DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension

Read the detailed description

To compare the different dose of DM combine with amlodipine in the treatment of mild to moderate essential hypertension, and to define the optimized dose of DM in the combination therapy.

The purpose of this study is to compare the antihypertensive efficacy and tolerability of different dose of DM combines with amlodipine treatment, further to explore the optimized combination dose of DM.

Conditions: Hypertension
Being tested: AM 5 + DM 0, AM 5 + DM 2.5, AM 5 + DM 7.5, AM 5 + DM 30
Keywords: amlodipine, DMTA07, hypertension
Medical subject headings: Hypertension

What participants receive

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

AM 5 + DM 0Drug
Also called Amlodipine (AM), DMTA07 (DM)
Amlodipine 5 mg + DMTA07 0mg, once daily
AM 5 + DM 2.5Drug
Also called Amlodipine (AM), DMTA07 (DM)
Amlodipine 5 mg + DMTA07 2.5mg, once daily
AM 5 + DM 7.5Drug
Also called Amlodipine (AM), DMTA07 (DM)
Amlodipine 5 mg + DMTA07 7.5mg, once daily
AM 5 + DM 30Drug
Also called Amlodipine (AM), DMTA07 (DM)
Amlodipine 5 mg + DMTA07 30mg, once daily

Study groups in NCT01614366
Study group	Role	What they receive
AM 5 + DM 0	Active comparator	Amlodipine 5 mg + DMTA07 0mg, once daily Receives: Drug: AM 5 + DM 0
AM 5 + DM 2.5	Experimental	Amlodipine 5 mg + DMTA07 2.5mg, once daily Receives: Drug: AM 5 + DM 0; Drug: AM 5 + DM 2.5
AM 5 + DM 7.5	Experimental	Amlodipine 5 mg + DMTA07 7.5mg, once daily Receives: Drug: AM 5 + DM 0; Drug: AM 5 + DM 2.5; Drug: AM 5 + DM 7.5
AM 5 + DM 30	Experimental	Amlodipine 5 mg + DMTA07 30mg, once daily Receives: Drug: AM 5 + DM 0; Drug: AM 5 + DM 2.5; Drug: AM 5 + DM 7.5; Drug: AM 5 + DM 30

What is being measured

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

*SBP reduction=SBP each visit- SBPvisit2
The primary objective of this study is to compare the sitting systolic blood pressure (mmHg) reduction* between four dose regimens, the baseline is defined as the actual SBP value after 2 weeks of amlodipine run-in period
Measured: 14 weeks

Secondary outcomes (1)

The secondary objectives of the study include: Efficacy/Safety
Efficacy:
To compare the sitting diastolic blood pressure (mmHg) reduction* between four dose regimens, the baseline is defined as the actual DBP value after 2 weeks of amlodipine run-in period To evaluate the percentage of SBP reduction in four treatment regimens To evaluate the changes of blood pressure (mmHg) in different clusters; such as diabetes etc.
Safety:
To evaluate the pulse rate changes To evaluate incidences of adverse events To evaluate the change of laboratory test results from baseline
Measured: 14 weeks

Timeline

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

Jul 2012May 2014

First posted7 Jun 2012 (estimated)
Study startJul 2012
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
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: Non-randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Participant
Enrolment: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01614366
Sponsor's protocol ID: TSHDM1101
Other IDs: DMTA07
Status last verified: Nov 2015
First submitted: 3 Jun 2012
Last updated: 13 Nov 2015
Results posted: No
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?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study to Explore the Effect of Different Dose of DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension
ClinicalTrials.gov ID: NCT01614366
Acronym / sponsor ID: TSHDM1101
Conditions: Hypertension
Keywords: amlodipine, DMTA07, hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 111 participants (actual)
Lead sponsor: TSH Biopharm Corporation LimitedIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 7 Jun 2012 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

To compare the different dose of DM combine with amlodipine in the treatment of mild to moderate essential hypertension, and to define the optimized dose of DM in the combination therapy.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
AM 5 + DM 0	Active comparator	Drug: AM 5 + DM 0Amlodipine 5 mg + DMTA07 0mg, once daily
AM 5 + DM 2.5	Experimental	Drug: AM 5 + DM 0, Drug: AM 5 + DM 2.5Amlodipine 5 mg + DMTA07 2.5mg, once daily
AM 5 + DM 7.5	Experimental	Drug: AM 5 + DM 0, Drug: AM 5 + DM 2.5, Drug: AM 5 + DM 7.5Amlodipine 5 mg + DMTA07 7.5mg, once daily
AM 5 + DM 30	Experimental	Drug: AM 5 + DM 0, Drug: AM 5 + DM 2.5, Drug: AM 5 + DM 7.5, Drug: AM 5 + DM 30Amlodipine 5 mg + DMTA07 30mg, once daily

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female patient aged between 50 to 75 years old (both included);
Patient with mild to moderate essential hypertension at enrollment, which defined as the following:
Patient must have mean sitting SBP ≥140 and <180 mmHg or mean sitting DBP ≥90 and <110 mmHg at enrollment;
Patient with normal serum potassium;
Patient or his/her legally acceptance representative has signed the written informed consent form.

Key exclusion criteria (18 listed)

Patient with severe hypertension (mean sitting DBP ≥ 110 mmHg or mean sitting SBP ≥ 180 mmHg);
Patient with secondary hypertension, such as coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc;
Patient is under treatment with beta-blocker prior to enrollment;
A definite diagnosis or unstable of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, arrhythmia and heart failure within 3 months before signing the written informed consent form;
Patient with concomitant endocrine diseases or type 1 Diabetes Mellitus;

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
AM 5 + DM 0Also: Amlodipine (AM), DMTA07 (DM)Amlodipine 5 mg + DMTA07 0mg, once daily	Drug	AM 5 + DM 0, AM 5 + DM 2.5, AM 5 + DM 30, AM 5 + DM 7.5
AM 5 + DM 2.5Also: Amlodipine (AM), DMTA07 (DM)Amlodipine 5 mg + DMTA07 2.5mg, once daily	Drug	AM 5 + DM 2.5, AM 5 + DM 30, AM 5 + DM 7.5
AM 5 + DM 7.5Also: Amlodipine (AM), DMTA07 (DM)Amlodipine 5 mg + DMTA07 7.5mg, once daily	Drug	AM 5 + DM 30, AM 5 + DM 7.5
AM 5 + DM 30Also: Amlodipine (AM), DMTA07 (DM)Amlodipine 5 mg + DMTA07 30mg, once daily	Drug	AM 5 + DM 30

Primary outcome

*SBP reduction=SBP each visit- SBPvisit2
Time frame: 14 weeks
The primary objective of this study is to compare the sitting systolic blood pressure (mmHg) reduction* between four dose regimens, the baseline is defined as the actual SBP value after 2 weeks of amlodipine run-in period

1 secondary outcome

The secondary objectives of the study include: Efficacy/Safety
Time frame: 14 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.

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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.

Jaw-Wen Chen, Doctor principal investigator

VGHTP

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AM 5 + DM 0, AM 5 + DM 2.5 and AM 5 + DM 7.5 in people with Hypertension, run by TSH Biopharm Corporation Limited at 8 sites in Taiwan.

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 5 inclusion and 18 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 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Taiwan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

*SBP reduction=SBP each visit- SBPvisit2 (time frame: 14 weeks). 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 NCT01614366.

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 13 Nov 2015.