Clinical trial NCT01614366: DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension
Official title: A Phase II Study to Explore the Effect of Different Dose of DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: amlodipine
DMTA07
hypertension
Lead sponsor: TSH Biopharm Corporation Limited
Sponsor class: INDUSTRY
First posted: 2012-06-07
Enrollment: 111
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female patient aged between 50 to 75 years old (both included);
2. 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;
3. Patient with normal serum potassium;
4. Patient or his/her legally acceptance representative has signed the written informed consent form.

Exclusion Criteria:

1. Patient with severe hypertension (mean sitting DBP ≥ 110 mmHg or mean sitting SBP ≥ 180 mmHg);
2. Patient with secondary hypertension, such as coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc;
3. Patient is under treatment with beta-blocker prior to enrollment;
4. 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;
5. Patient with concomitant endocrine diseases or type 1 Diabetes Mellitus;
6. 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;
7. Patient with clinically unstable disease such as known collagen or auto-immune disease or other malignant disease requiring current medication;
8. Patient with bilateral renal artery stenosis, solitary kidney or post renal transplant;
9. Patient with clinically relevant hematological disease;
10. 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;
11. Female patient who is pregnant or lactating;
12. Patient with substance abuse (including alcohol) history for the past two years;
13. Known or suspected contraindications, including allergy to DMTA07 or calcium channel blockers;
14. Patient received other investigational drug or device within 30 days before signing the written informed consent form;
15. Patient with any other serious disease considered by the investigator(s) not in the condition to enter the trial.

Primary outcomes:
measure: *SBP reduction=SBP each visit- SBPvisit2
timeFrame: 14 weeks
Secondary outcomes:
measure: The secondary objectives of the study include: Efficacy/Safety
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-DA Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: VGHTP
name: Jaw-Wen Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
References: