DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TSH Biopharm Corporation Limited
ClinicalTrials.gov Identifier:
NCT01614366
First received: June 3, 2012
Last updated: November 11, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Hypertension
Drug: AM 5 + DM 0
Drug: AM 5 + DM 2.5
Drug: AM 5 + DM 7.5
Drug: AM 5 + DM 30
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Phase II Study to Explore the Effect of Different Dose of DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension

Resource links provided by NLM:


Further study details as provided by TSH Biopharm Corporation Limited:

Primary Outcome Measures:
  • *SBP reduction=SBP each visit- SBPvisit2 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • The secondary objectives of the study include: Efficacy/Safety [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]

    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



Enrollment: 111
Study Start Date: July 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AM 5 + DM 0
Amlodipine 5 mg + DMTA07 0mg, once daily
Drug: AM 5 + DM 0
Amlodipine 5 mg + DMTA07 0mg, once daily
Other Names:
  • Amlodipine (AM)
  • DMTA07 (DM)
Experimental: AM 5 + DM 2.5
Amlodipine 5 mg + DMTA07 2.5mg, once daily
Drug: AM 5 + DM 0
Amlodipine 5 mg + DMTA07 0mg, once daily
Other Names:
  • Amlodipine (AM)
  • DMTA07 (DM)
Drug: AM 5 + DM 2.5
Amlodipine 5 mg + DMTA07 2.5mg, once daily
Other Names:
  • Amlodipine (AM)
  • DMTA07 (DM)
Experimental: AM 5 + DM 7.5
Amlodipine 5 mg + DMTA07 7.5mg, once daily
Drug: AM 5 + DM 0
Amlodipine 5 mg + DMTA07 0mg, once daily
Other Names:
  • Amlodipine (AM)
  • DMTA07 (DM)
Drug: AM 5 + DM 2.5
Amlodipine 5 mg + DMTA07 2.5mg, once daily
Other Names:
  • Amlodipine (AM)
  • DMTA07 (DM)
Drug: AM 5 + DM 7.5
Amlodipine 5 mg + DMTA07 7.5mg, once daily
Other Names:
  • Amlodipine (AM)
  • DMTA07 (DM)
Experimental: AM 5 + DM 30
Amlodipine 5 mg + DMTA07 30mg, once daily
Drug: AM 5 + DM 0
Amlodipine 5 mg + DMTA07 0mg, once daily
Other Names:
  • Amlodipine (AM)
  • DMTA07 (DM)
Drug: AM 5 + DM 2.5
Amlodipine 5 mg + DMTA07 2.5mg, once daily
Other Names:
  • Amlodipine (AM)
  • DMTA07 (DM)
Drug: AM 5 + DM 7.5
Amlodipine 5 mg + DMTA07 7.5mg, once daily
Other Names:
  • Amlodipine (AM)
  • DMTA07 (DM)
Drug: AM 5 + DM 30
Amlodipine 5 mg + DMTA07 30mg, once daily
Other Names:
  • Amlodipine (AM)
  • DMTA07 (DM)

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

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614366

Locations
Taiwan
E-DA Hospital
Kaohsiung, Taiwan, 824
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
National Taiwan University Hospital
Taipei, Taiwan, 100
Mackay Memorial Hospital
Taipei, Taiwan, 104
Cheng Hsin General Hospital
Taipei, Taiwan, 112
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Tri-Service General Hospital
Taipei, Taiwan, 114
Chang Gung Memorial Hospital
Taoyuan County, Taiwan, 333
Sponsors and Collaborators
TSH Biopharm Corporation Limited
Investigators
Principal Investigator: Jaw-Wen Chen, Doctor VGHTP
  More Information

No publications provided

Responsible Party: TSH Biopharm Corporation Limited
ClinicalTrials.gov Identifier: NCT01614366     History of Changes
Other Study ID Numbers: TSHDM1101  DMTA07 
Study First Received: June 3, 2012
Last Updated: November 11, 2015
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by TSH Biopharm Corporation Limited:
amlodipine
DMTA07
hypertension

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on February 04, 2016