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DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension

11. november 2015 opdateret af: TSH Biopharm Corporation Limited

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

111

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: AM 5 + DM 0
Amlodipine 5 mg + DMTA07 0mg, once daily
Medicin: AM 5 + DM 0
Amlodipine 5 mg + DMTA07 0mg, once daily
Andre navne:
  • Amlodipine (AM)
  • DMTA07 (DM)
Eksperimentel: AM 5 + DM 2.5
Amlodipine 5 mg + DMTA07 2.5mg, once daily
Medicin: AM 5 + DM 0
Amlodipine 5 mg + DMTA07 0mg, once daily
Andre navne:
  • Amlodipine (AM)
  • DMTA07 (DM)
Medicin: AM 5 + DM 2.5
Amlodipine 5 mg + DMTA07 2.5mg, once daily
Andre navne:
  • Amlodipine (AM)
  • DMTA07 (DM)
Eksperimentel: AM 5 + DM 7.5
Amlodipine 5 mg + DMTA07 7.5mg, once daily
Medicin: AM 5 + DM 0
Amlodipine 5 mg + DMTA07 0mg, once daily
Andre navne:
  • Amlodipine (AM)
  • DMTA07 (DM)
Medicin: AM 5 + DM 2.5
Amlodipine 5 mg + DMTA07 2.5mg, once daily
Andre navne:
  • Amlodipine (AM)
  • DMTA07 (DM)
Medicin: AM 5 + DM 7.5
Amlodipine 5 mg + DMTA07 7.5mg, once daily
Andre navne:
  • Amlodipine (AM)
  • DMTA07 (DM)
Eksperimentel: AM 5 + DM 30
Amlodipine 5 mg + DMTA07 30mg, once daily
Medicin: AM 5 + DM 0
Amlodipine 5 mg + DMTA07 0mg, once daily
Andre navne:
  • Amlodipine (AM)
  • DMTA07 (DM)
Medicin: AM 5 + DM 2.5
Amlodipine 5 mg + DMTA07 2.5mg, once daily
Andre navne:
  • Amlodipine (AM)
  • DMTA07 (DM)
Medicin: AM 5 + DM 7.5
Amlodipine 5 mg + DMTA07 7.5mg, once daily
Andre navne:
  • Amlodipine (AM)
  • DMTA07 (DM)
Medicin: AM 5 + DM 30
Amlodipine 5 mg + DMTA07 30mg, once daily
Andre navne:
  • Amlodipine (AM)
  • DMTA07 (DM)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
*SBP reduction=SBP each visit- SBPvisit2
Tidsramme: 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
14 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The secondary objectives of the study include: Efficacy/Safety
Tidsramme: 14 weeks

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
14 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

TSH Biopharm Corporation Limited

Efterforskere

  • Ledende efterforsker: Jaw-Wen Chen, Doctor, VGHTP

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2012

Primær færdiggørelse (Faktiske)

1. maj 2014

Studieafslutning (Faktiske)

1. maj 2014

Datoer for studieregistrering

Først indsendt

3. juni 2012

Først indsendt, der opfyldte QC-kriterier

5. juni 2012

Først opslået (Skøn)

7. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. november 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. november 2015

Sidst verificeret

1. november 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TSHDM1101
  • DMTA07 (Anden identifikator: Tshbiopharm)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Forhøjet blodtryk

Kliniske forsøg med AM 5 + DM 0

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Pakistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner