DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension
A Phase II Study to Explore the Effect of Different Dose of DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension
2 other identifiers
interventional
111
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hypertension
Started Jul 2012
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2012
CompletedFirst Posted
Study publicly available on registry
June 7, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedNovember 13, 2015
November 1, 2015
1.8 years
June 3, 2012
November 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
*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
14 weeks
Secondary Outcomes (1)
The secondary objectives of the study include: Efficacy/Safety
14 weeks
Study Arms (4)
AM 5 + DM 0
ACTIVE COMPARATORAmlodipine 5 mg + DMTA07 0mg, once daily
AM 5 + DM 2.5
EXPERIMENTALAmlodipine 5 mg + DMTA07 2.5mg, once daily
AM 5 + DM 7.5
EXPERIMENTALAmlodipine 5 mg + DMTA07 7.5mg, once daily
AM 5 + DM 30
EXPERIMENTALAmlodipine 5 mg + DMTA07 30mg, once daily
Interventions
Amlodipine 5 mg + DMTA07 0mg, once daily
Amlodipine 5 mg + DMTA07 2.5mg, once daily
Amlodipine 5 mg + DMTA07 7.5mg, once daily
Amlodipine 5 mg + DMTA07 30mg, once daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- 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;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
E-DA Hospital
Kaohsiung City, 824, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Mackay Memorial Hospital
Taipei, 104, Taiwan
Cheng Hsin General Hospital
Taipei, 112, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Tri-Service General Hospital
Taipei, 114, Taiwan
Chang Gung Memorial Hospital
Taoyuan, 333, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaw-Wen Chen, Doctor
VGHTP
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2012
First Posted
June 7, 2012
Study Start
July 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
November 13, 2015
Record last verified: 2015-11