## Protocol Section
### Identification Module
**NCT ID:** NCT02152579

**Brief Title:** Efficacy and Safety of Monocordil Manufactured by Laboratórios Baldacci

**Official Title:** Open Monocentric Clinical Study for the Evaluation of Efficacy and Safety of 20 mg Monocordil Tablets Manufactured by Laboratórios Baldacci in Patients With Stable Angina

#### Organization Study ID Info
**ID:** ATC 001/14
#### Organization
**Class:** INDUSTRY
**Full Name:** Laboratórios Baldacci S.A
### Status Module
#### Completion Date
**Date:** 2014-10

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2014-06-02

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-05-30

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2014-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2014-07

**Status Verified Date:** 2014-05

#### Study First Post Date
**Date:** 2014-06-02
**Type:** ESTIMATED
**Study First Submit Date:** 2014-05-29
**Study First Submit QC Date:** 2014-05-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Laboratórios Baldacci S.A

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Phase III clinical study for the evaluation of clinic and cardiologic effects of isosorbide mononitrate from the incidence of events (angina episodes).

This is an open, comparative, monocentric trial. The hypothesis, regarding the number of angina episodes, to be tested are:

* H0: μD = 0 ot H0: μAfter = μBefore
* HA: μD ≠ 0 ot HA: μBefore ≠ μAfter

**Detailed Description:** Phase III study, monocentric, open, with a single treatment arm in patients with stable angina to evaluates efficacy and safety. The study will be sponsored by pelo Laboratórios Baldacci. All patients who participate in the study shall sign two copies of the informed consent form. The inclusion of patients is expected to last until 12 months from the approval of the Ethics Committee and ANVISA.

Follow up will last at least 2 weeks for each included patient. A total of 86 patients will be recruited for this study and all of them will initiate treatment with 20 mg monocordil tablets. After 2 consecutive weeks using the investigational product (+2 days), the patients will be evaluated again, particularly for the parameters under study, this is, quantity and severity of angina episodes and adverse events. The selected patients shall also be 18-80 years old of both genders, with proved diagnosis of stable angina through clinical exams such as ECG, physical effort tests or similar. Patients will receive 20mg monocordil tablets (Baldacci Laboratories).

The evaluations will take place in two opportunities: one at the visit of medical evaluation and recruitment in the study (along with the deliver of the study medication and a diary) and the second one after 2 weeks (+2 days) of use of 20mg monocordil tablets for medical evaluation and discharge of the study (return of the diary and medication accountability).

### Conditions Module

**Conditions:**

- Stable Angina

**Keywords:**

- Stable Angina

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 86

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Single treatment arm.

**Intervention Names:**

- Drug: Isosorbide-5-mononitrate

**Label:** Isosorbide-5-mononitrate, tablet

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Isosorbide-5-mononitrate, tablet

**Description:** Patients will receive 20mg monocordil tablets (Baldacci Laboratories).

**Name:** Isosorbide-5-mononitrate

**Other Names:**

- Monocordil

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The absolute parameter of incidence of improvement will be used as primary endpoint, being considered as improvement the reduction in the number of events in 15 days, after the beginning of the intake of the study medication, and the intensity of the angina crisis

**Measure:** Absolute number of episodes of angina

**Time Frame:** 15 days

#### Secondary Outcomes

**Description:** The secondary endpoints to be used are the other parameters supplied by the diary (incidence and intensity of Adverse Events).

**Measure:** Adverse events

**Time Frame:** 15 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Capacity for understanding and agreement in signing the informed consent form
* Age 18 between 18 and 80 years old
* Have a diagnosis of stable angina, proved by ECG, test of physical effort or similar
* Not being under treatment with other nitrate for stable angina
* Medical indication for the use of isosorbide mononitrate (Monocordil)

Exclusion Criteria:

* Presence or serious comorbidities (under judgement of the investigator)
* Allergy to any of the component of the investigational product
* Pregnant female patients, brest feeding and/or in fertile condition who wish to get pregnant during the study and deny the use of contraceptives

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** rodrigo_modolo@yahoo.com.br

**Name:** Rodrigo G Modolo, MD

**Phone:** 55 19 3305 7391

**Role:** CONTACT

**Contact 2:**

**Email:** carsver@atcgen.com.br

**Name:** Carlos Sverdloff, MSc

**Phone:** 19 98121 8440

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Campinas

**Contacts:**

***Contact 1:***

- **Email:** rodrigo_modolo@yahoo.com.br

- **Name:** Rodrigo G Modolo, MD

- **Phone:** 55 19 3232 8524

- **Role:** CONTACT

**Country:** Brazil

**Facility:** Clinicordis

**State:** SP

**Zip:** 13076 628

#### Overall Officials

**Official 1:**

**Affiliation:** ATCGen

**Name:** Rodrigo G Modolo, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002637

- Term: Chest Pain

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4117

- Name: Angina Pectoris

- Relevance: HIGH

- As Found: Angina

- ID: M29575

- Name: Angina, Stable

- Relevance: HIGH

- As Found: Stable Angina

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M5882

- Name: Chest Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000787

- Term: Angina Pectoris

- ID: D000060050

- Term: Angina, Stable

### Intervention Browse Module - Ancestors

- ID: D000004234

- Term: Diuretics, Osmotic

- ID: D000004232

- Term: Diuretics

- ID: D000045283

- Term: Natriuretic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000014665

- Term: Vasodilator Agents

- ID: D000020030

- Term: Nitric Oxide Donors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: NaAg

- Name: Natriuretic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: NiOxD

- Name: Nitric Oxide Donors

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: Resp

- Name: Respiratory System Agents

### Intervention Browse Module - Browse Leaves

- ID: M10578

- Name: Isosorbide

- Relevance: HIGH

- As Found: 210

- ID: M10579

- Name: Isosorbide Dinitrate

- Relevance: HIGH

- As Found: Urinary urgency

- ID: M244430

- Name: Isosorbide-5-mononitrate

- Relevance: HIGH

- As Found: Urinary urgency

- ID: M7411

- Name: Diuretics

- Relevance: LOW

- As Found: Unknown

- ID: M17412

- Name: Vasodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M12507

- Name: Nitric Oxide

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007547

- Term: Isosorbide

- ID: D000007548

- Term: Isosorbide Dinitrate

- ID: C000030397

- Term: Isosorbide-5-mononitrate

### Misc Info Module

- Version Holder: 2024-05-24
