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

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03226340
• Other study ID #: HL_LDN_504
• Status: Recruiting
• Phase: Phase 4
• First received: July 17, 2017
• Last updated: July 20, 2017
• Start date: December 2, 2015
• Est. completion date: March 31, 2018

Study information

• Verified date: July 2017
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• S-amlodipine 2.5mg + Chlorthalidone 25mg
patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks.
• S-amlodipine 2.5mg + Telmisartan 40mg
patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang	Dongan-gu
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Hallym University Medical Center	Seoul	Gangdong-gu,
Korea, Republic of	Hanyang University Medical Center	Seoul	Seongdong-gu
Korea, Republic of	Korea Univ. Guro Hospital	Seoul	Guro
Korea, Republic of	Kyung Hee University Hospital	Seoul	Dongdaemun-gu
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-Gu
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu
Korea, Republic of	Ajou Univ. Medical Center	Suwon-si	Yeong-tong

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sit diastolic blood pressure	Mean change in sit diastolic blood pressure after 12 weeks compared to baseline.	12 weeks
Secondary	sit diastolic blood pressure	Mean change in sit diastolic blood pressure after 6 weeks compared to baseline.	6 weeks
Secondary	sit systolic blood pressure	Mean change in sit systolic blood pressure after 6 weeks and 12 weeks compared to baseline.	12 weeks
Secondary	Blood pressure normalization	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