NCT01983735

Brief Summary

The aim of present study is to evaluate the efficacy and safety of two dose combination of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.

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
200

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 7, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 14, 2013

Status Verified

November 1, 2013

Enrollment Period

7 months

First QC Date

November 7, 2013

Last Update Submit

November 7, 2013

Conditions

Hypertension

Keywords

TELMINUVO Tab.CKD-828HypertensionStage 2 HypertensionS-AmlodipineTelmisartan

Outcome Measures

Primary Outcomes (1)

  • Mean Sitting Systolic Blood Pressure (MSSBP)

    After 8 weeks of treatment

Secondary Outcomes (4)

  • Mean Sitting Systolic Blood Pressure (MSSBP)

    After 2 weeks and 4 weeks of treatment

  • Mean Sitting Diastolic Blood Pressure (MSDBP)

    After 2weeks, 4weeks and 8 weeks of treatment

  • Control Rate

    After 8 weeks of treatment

  • Response Rate

    After 8 weeks of treatment

Study Arms (2)

TELMINUVO Tab. (80/2.5mg, 80/5mg)

EXPERIMENTAL
Drug: TELMINUVO Tab. (80/2.5mg)Drug: TELMINUVO Tab. (80/5mg)

S-Amlodipine 2.5, 5mg

ACTIVE COMPARATOR
Drug: S-amlodipine 2.5mgDrug: S-amlodipine 5mg

Interventions

TELMINUVO Tab. (80/2.5mg)DRUG

* Fixed dose combination of Telmisartan 80mg and S-amlodipine 2.5mg QD 2 weeks. * With the others investigation product placebo 1 tab QD 2 weeks.

Also known as: TELMINUVO Tab.
TELMINUVO Tab. (80/2.5mg, 80/5mg)
TELMINUVO Tab. (80/5mg)DRUG

* Fixed dose combination of Telmisartan 80mg and S-amlodipine 5mg QD 6 weeks. * With the others investigation product placebo 1 tab QD 6 weeks.

Also known as: TELMINUVO Tab.
TELMINUVO Tab. (80/2.5mg, 80/5mg)
S-amlodipine 2.5mgDRUG

* S-amlodipine 2.5mg QD 2 weeks * With the others investigation product placebo 1 tab QD 2 weeks.

Also known as: Anydipine S
S-Amlodipine 2.5, 5mg
S-amlodipine 5mgDRUG

* S-amlodipine 5mg QD 6weeks * With the others investigation product placebo 1 tab QD 6 weeks.

Also known as: Anydipine S
S-Amlodipine 2.5, 5mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 years or older
  • at the screening visit
  • antihypertensive drugs not taking: 160mmHg ≤ sitSBP \< 200mmHg
  • antihypertensive drugs taking: 140mmHg ≤ sitSBP \< 180mmHg
  • at the randomization visit(160mmHg ≤ sitSBP \< 200mmHg)
  • willing and able to provide written informed consent

You may not qualify if:

  • mean sitting DBP ≥ 120mmHg or mean sitting SBP ≥ 200mmHg at the screening visit and randomization visit
  • for the past four weeks based on beginning of administration, patients took over four antihypertensive drugs
  • known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
  • has severe heart disease(Heart failure NYHA functional class 3, 4), ischaemic heart diseases status need to treatment, myocardiopathy, Valve disease, arrhythmia and so on and operated Coronary angioplasty
  • has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
  • Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) \> 8%)
  • known severe or malignant retinopathy
  • defined by the following laboratory parameters:
  • hepatic dysfunction(AST/ALT \> UNL X 3)
  • renal dysfunction(serum creatinine \> UNL X 1.5)
  • hypopotassemia(K \< 3.0mmol/L) or hyperpotassemia (K\>5.5 mmol/L)
  • acute or chronic inflammatory status need to treatment
  • need to additional antihypertensive drugs during the study
  • need to concomitant medications known to affect blood pressure during the study
  • history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The catholic university of Korea Seoul St. Mary's hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

levamlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Ho-Joong Yoon, Ph.D

CONTACT

82-2-2258-6029younhj@catholic.ac.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 14, 2013

Study Start

January 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

November 14, 2013

Record last verified: 2013-11

Locations

KR(1)