S-amlodipine+Chlorthalidone vs S-amlodipine+Telmisartan in Hypertension

July 20, 2017 updated by: Dong-Ju Choi, Seoul National University Bundang Hospital

Evaluation of the Efficacy and Safety of S-amlodipine+Chlorthalidone Combination Therapy and S-amlodipine+Telmisartan Combination Therapy in Hypertensive Patients Inadequately Controlled With Calcium Channel Blocker Monotherapy

Evaluation of the Efficacy and Safety of S-amlodipine+Chlorthalidone Combination Therapy and S-amlodipine+Telmisartan Combination Therapy in Hypertensive Patients Inadequately Controlled With CCB(Calcium Channel Blocker) Monotherapy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to verify the difference at week 12 from the baseline value in the average variation of diastolic blood pressure (sitDBP) of the study group in which S-amlodipine / Chlorthalidone combination therapy is to be used in patients with essential hypertension who did not adequately respond to monotherapy of amlodipine or S-amlodipine, compared to the control group, in which a combination therapy of S-amlodipine / telmisartan is to be used.

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seongnam, Korea, Republic of, 463707
        • Recruiting
        • Seoul National University Bundang Hospital
    • Dongan-gu
      • Anyang, Dongan-gu, Korea, Republic of, 14068
        • Recruiting
        • Hallym University Medical Center
        • Contact:
    • Dongdaemun-gu
      • Seoul, Dongdaemun-gu, Korea, Republic of, 02447
        • Recruiting
        • Kyung Hee University Hospital
        • Contact:
    • Gangdong-gu,
      • Seoul, Gangdong-gu,, Korea, Republic of, 05355
        • Recruiting
        • Hallym University Medical Center
        • Contact:
    • Gangnam-Gu
      • Seoul, Gangnam-Gu, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
    • Guro
      • Seoul, Guro, Korea, Republic of, 08308
        • Recruiting
        • Korea Univ. Guro hospital
        • Contact:
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
    • Seongdong-gu
      • Seoul, Seongdong-gu, Korea, Republic of, 04763
        • Recruiting
        • Hanyang University Medical Center
        • Contact:
    • Songpa-gu
      • Seoul, Songpa-gu, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
    • Yeong-tong
      • Suwon-si, Yeong-tong, Korea, Republic of, 16499
        • Recruiting
        • Ajou Univ. Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men and women with essential hypertension who were aged 19 years or older and younger than 80 years
  2. Patients who have been treated with amlodipine or S-amlodipine monotherapy for more than 2 weeks immediately before visit 1 (screening)
  3. Visit 1 (screening) reference mean blood pressure measured three times in the arm is greater than sit DBP 90 mmHg
  4. Those who have voluntarily agreed in writing to participate in the trial

Exclusion Criteria:

  1. Patients with a history of secondary hypertension and all those with suspected secondary hypertension (including, but not limited to, coarctation of the aorta, primary aldosteronism, renal artery stenosis, Cushing's syndrome, chromium-rich cell tumor, polycystic kidney disease, etc.)
  2. Patients with a mean SBP of 200 mmHg or more or a sit DBP of 110 mmHg or more at visit 1.
  3. When the blood pressure was measured three times in the reference arm of visit 1 (screening), the difference between the highest lowest sit SBP was 20 mmHg or higher and the difference between the highest lowest sit DBP was 10 mmHg or higher.
  4. An uncontrolled diabetic patient(HbA1c≥9.0%)
  5. In addition to antihypertensive drugs, drugs that may affect blood pressure( Systemic steroids, Thyroid hormones, Oral contraceptives, antipsychotic drugs, NSAIDs, sympathomimetics, immunosuppressants, etc.) have been continuously administered for more than 12 weeks prior to visit 1 (screening)
  6. Patients who are expected to take antihypertensive drugs other than clinical drugs during the trial
  7. Patients with orthostatic hypotension with symptoms
  8. Patients with a history of malignant tumors including leukemia and lymphoma within the past 5 years
  9. Patients with a history of autoimmune diseases such as chronic joint rheumatism and systemic lupus erythematosus
  10. Those who have a history of hypersensitivity to the amlodipine nicotinate or other chlortalidone or telmisartan drug

  11. Patients with clinically significant renal • hepatic disease such as those on dialysis, cirrhosis, biliary obstruction, hepatic failure, or those who have the following findings on visit 1 (screening)

    • ALanine Transaminase or ASpartate Transaminase is more than 3 times the normal upper limit
    • Total bilirubin more than twice the normal upper limit
    • More than twice the Blood Urea Nitrogen normal upper limit
    • Alkaline Phosphatase More than twice the normal upper limit - Creatinine Clearance Less than 10 mL / min

  12. Within the last 6 months, patients who have received the following diseases or treatments and whose clinical judgment is meaningful to the researcher

    • Severe heart disease (heart failure New York Heart Association class III and IV), ischemic heart disease, peripheral vascular disease, hemodynamically significant valve stenosis, arrhythmia, etc
    • Patients with severe cerebrovascular disorders (stroke, cerebral infarction, cerebral hemorrhage, etc.)
  13. Shock patient
  14. Patients with clinical history of alcohol or substance abuse

  15. Patients with potential pregnancy or breastfeeding

    • In the case of pregnant women, if the negative is not confirmed during pregnancy test
    • Women who did not consent to contraception in a medically acceptable way during the trial
    • Medically acceptable contraceptive methods: use condoms, injectable or injectable contraceptives, intrauterine contraceptive device, etc.
  16. If the tester judges that the participation in the clinical trial is not legal or mental character
  17. Clinical studies with other clinical trial drugs within 4 weeks prior to screening patients with experience

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-amlodipine + Chlorthalidone
patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks.
Drug: S-amlodipine 2.5mg + Chlorthalidone 25mg
patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks.
Active Comparator: S-amlodipine + Telmisartan
patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks.
Drug: S-amlodipine 2.5mg + Telmisartan 40mg
patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sit diastolic blood pressure
Time Frame: 12 weeks
Mean change in sit diastolic blood pressure after 12 weeks compared to baseline.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sit diastolic blood pressure
Time Frame: 6 weeks
Mean change in sit diastolic blood pressure after 6 weeks compared to baseline.
6 weeks
sit systolic blood pressure
Time Frame: 12 weeks
Mean change in sit systolic blood pressure after 6 weeks and 12 weeks compared to baseline.
12 weeks
Blood pressure normalization
Time Frame: 12 weeks
Blood pressure normalization ratio after 12 weeks compared to baseline( sit systolic blood pressure <140 mmHg or sit diastolic blood pressure <90 mmHg).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Hanlim Pharm. Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2015

Primary Completion (Anticipated)

March 31, 2018

Study Completion (Anticipated)

March 31, 2018

Study Registration Dates

First Submitted

July 17, 2017

First Submitted That Met QC Criteria

July 20, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 20, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL_LDN_504

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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