## Protocol Section
### Identification Module
**NCT ID:** NCT06431477

**Brief Title:** Efficacy and Safety of Telmisartan Compared With Losartan

**Official Title:** A Multi-center, Randomized, Open-label, Active Comparator-controlled, Phase 4 Clinical Trial To Evaluate the Efficacy and Safety of Telmisartan Compared With Losartan in Patients With Diabetic Nephropathy and Hypertension

#### Organization Study ID Info
**ID:** B115_02HT/DN2201
#### Organization
**Class:** INDUSTRY
**Full Name:** Chong Kun Dang Pharmaceutical
### Status Module
#### Completion Date
**Date:** 2025-10-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-10-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-04-19

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Chong Kun Dang Pharmaceutical

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A study to evaluate the efficacy and safety of telmisartan compared with losartan in patients with diabetic nephropathy and hypertension

**Detailed Description:** A Multi-center, Randomized, Open-label, Active comparator-controlled, Phase 4 Clinical Trial To Evaluate the Efficacy and Safety of Telmisartan Compared with Losartan in Patients with Diabetic Nephropathy and Hypertension

### Conditions Module

**Conditions:**

- Diabetic Nephropathies

- Hypertension

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 98

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: telmisartan

**Label:** Telmisartan tablet

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Losartan

**Label:** Losartan tablet

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Telmisartan tablet

**Description:** QD, PO

**Name:** telmisartan

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Losartan tablet

**Description:** QD, PO

**Name:** Losartan

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change rate from baseline in Spot-UACR(Albumin/Creatinine Ratio)

**Time Frame:** 24 weeks after drug administration

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male of Female subjects aged ≥19 or \<75
* Type II Diabetes Mellitus subjects who have been taken medicine
* Subjects who have voluntarily decided to participate in this clinical trial and Signed ICF

Exclusion Criteria:

* Subjects with Type I Diabetes Mellitus
* Subjects with Primary hyper-aldosteronism
* Subjects with a history of drug or alcohol abuse or suspected patient within 1 year as of the time of screening
* Pregnant women, lactating women, or subjects who do not agree to use appropriate contraception during the clinical trial period
* Subjects who received other clinical trial drugs within 28 days of screening visit
* Subjects who are unable to participate in this clinical trial at the discretion of the investigator.

**Maximum Age:** 75 Years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** DOCBSK@yuhs.ac

**Name:** BeomSeok Kim, M.D, Ph.D

**Phone:** +82-2-2228-5331

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Email:** DOCBSK@yuhs.ac

- **Name:** BeomSeok Kim, M.D, Ph.D

- **Phone:** +02-2228-5331

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Severance Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Severance Hospital

**Name:** BeomSeok Kim, M.D, Ph.D

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000048909

- Term: Diabetes Complications

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Nephropathy

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M7123

- Name: Diabetic Nephropathies

- Relevance: HIGH

- As Found: Diabetic Nephropathy

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M26004

- Name: Diabetes Complications

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007674

- Term: Kidney Diseases

- ID: D000003928

- Term: Diabetic Nephropathies

- ID: D000006973

- Term: Hypertension

### Intervention Browse Module - Ancestors

- ID: D000000889

- Term: Anti-Arrhythmia Agents

- ID: D000000959

- Term: Antihypertensive Agents

- ID: D000047228

- Term: Angiotensin II Type 1 Receptor Blockers

- ID: D000057911

- Term: Angiotensin Receptor Antagonists

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: AnAg

- Name: Antihypertensive Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

### Intervention Browse Module - Browse Leaves

- ID: M21701

- Name: Losartan

- Relevance: HIGH

- As Found: Living

- ID: M1770

- Name: Telmisartan

- Relevance: HIGH

- As Found: Self-management

- ID: M4213

- Name: Anti-Arrhythmia Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4277

- Name: Antihypertensive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4132

- Name: Angiotensin II

- Relevance: LOW

- As Found: Unknown

- ID: M289354

- Name: Giapreza

- Relevance: LOW

- As Found: Unknown

- ID: M4135

- Name: Angiotensinogen

- Relevance: LOW

- As Found: Unknown

- ID: M25789

- Name: Angiotensin II Type 1 Receptor Blockers

- Relevance: LOW

- As Found: Unknown

- ID: M28916

- Name: Angiotensin Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000019808

- Term: Losartan

- ID: D000077333

- Term: Telmisartan

### Misc Info Module

- Version Holder: 2024-05-31
