NCT03226340

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2015

Typical duration for phase_4

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

2.3 years

First QC Date

July 17, 2017

Last Update Submit

July 20, 2017

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

  • sit diastolic blood pressure

    Mean change in sit diastolic blood pressure after 12 weeks compared to baseline.

    12 weeks

Secondary Outcomes (3)

  • sit diastolic blood pressure

    6 weeks

  • sit systolic blood pressure

    12 weeks

  • Blood pressure normalization

    12 weeks

Study Arms (2)

S-amlodipine + Chlorthalidone

EXPERIMENTAL

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

Drug: S-amlodipine 2.5mg + Chlorthalidone 25mg

S-amlodipine + Telmisartan

ACTIVE COMPARATOR

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

Drug: S-amlodipine 2.5mg + Telmisartan 40mg

Interventions

S-amlodipine 2.5mg + Chlorthalidone 25mgDRUG

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

S-amlodipine + Chlorthalidone
S-amlodipine 2.5mg + Telmisartan 40mgDRUG

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

S-amlodipine + Telmisartan

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.)
  • Patients with a mean SBP of 200 mmHg or more or a sit DBP of 110 mmHg or more at visit 1.
  • 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.
  • An uncontrolled diabetic patient(HbA1c≥9.0%)
  • 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)
  • Patients who are expected to take antihypertensive drugs other than clinical drugs during the trial
  • Patients with orthostatic hypotension with symptoms
  • Patients with a history of malignant tumors including leukemia and lymphoma within the past 5 years
  • Patients with a history of autoimmune diseases such as chronic joint rheumatism and systemic lupus erythematosus
  • Those who have a history of hypersensitivity to the amlodipine nicotinate or other chlortalidone or telmisartan drug
  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hallym University Medical Center

Anyang, Dongan-gu, 14068, South Korea

RECRUITING

Kyung Hee University Hospital

Seoul, Dongdaemun-gu, 02447, South Korea

RECRUITING

Hallym University Medical Center

Seoul, Gangdong-gu,, 05355, South Korea

RECRUITING

Samsung Medical Center

Seoul, Gangnam-Gu, 06351, South Korea

RECRUITING

Korea Univ. Guro Hospital

Seoul, Guro, 08308, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

Hanyang University Medical Center

Seoul, Seongdong-gu, 04763, South Korea

RECRUITING

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

RECRUITING

Ajou Univ. Medical Center

Suwon, Yeong-tong, 16499, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam, 463707, South Korea

RECRUITING

Related Publications (1)

  • Jo SH, Park SJ, Kim EJ, Kim SJ, Cho HJ, Song JM, Shin J, Park JJ, Shin JH, Han KR, Choi DJ. S-amlodipine plus chlorthalidone vs. S-amlodipine plus telmisartan in hypertensive patients unresponsive to amlodipine monotherapy: study protocol for a randomized controlled trial. Trials. 2018 Jun 20;19(1):324. doi: 10.1186/s13063-018-2636-1.

    PMID: 29925421DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

levamlodipineChlorthalidoneTelmisartan

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsBenzophenonesPhthalimidesImidesKetonesSulfonesSulfur CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBiphenyl CompoundsBenzimidazoles

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 21, 2017

Study Start

December 2, 2015

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

KR(10)