## Protocol Section
### Identification Module
**NCT ID:** NCT00669279

**Brief Title:** Effect of Carvedilol Controlled-Release (CR) and Atenolol on Central Blood Pressure

**Official Title:** Non-Invasive Determination of Central Aortic Blood Pressure in Hypertensive Patients Treated With Controlled-Release Carvedilol or Atenolol

#### Organization Study ID Info
**ID:** 8COG11059
#### Organization
**Class:** OTHER
**Full Name:** University of Florida
### Status Module
#### Completion Date
**Date:** 2010-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-10-05

**Type:** ACTUAL

**Last Update Submit Date:** 2017-09-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-07

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2012-03-23

**Type:** ESTIMATED

**Results First Submit Date:** 2011-12-05

**Results First Submit QC Date:** 2012-02-17

#### Start Date
**Date:** 2008-04

**Status Verified Date:** 2017-09

#### Study First Post Date
**Date:** 2008-04-30
**Type:** ESTIMATED
**Study First Submit Date:** 2008-04-28
**Study First Submit QC Date:** 2008-04-29
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** GlaxoSmithKline

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Florida

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this research study is to determine whether atenolol or controlled release carvedilol lower blood pressure in the body as effectively as in the arm. Blood pressure measured in the aorta, a large blood vessel carrying blood away from the heart, may be a better measure of the harmful effects of high blood pressure on the body's organs. In the past, blood pressure has only been measured in the arms. However, blood pressure in the arms may not accurately reflect the blood pressure in the aorta and thus may mislead doctors treating high blood pressure. For this reason, we are testing whether two different medications for blood pressure, both in a class called beta blockers, have similar effects on blood pressure in the arm and aorta.

**Detailed Description:** Carvedilol reduces aortic wave reflection and improves left ventricular/vascular coupling: a comparison with atenolol (CENTRAL Study) is a prospective, open-label, comparative, randomized control trial that evaluated brachial and central hemodynamic profiles in patients taking atenolol or controlled-release carvedilol.

### Conditions Module

**Conditions:**

- Hypertension

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 41

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Carvedilol CR

**Label:** Carvedilol CR

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Atenolol

**Label:** Atenolol

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Carvedilol CR

**Description:** Dose titration of 20mg by mouth once daily for 1 week, then 40mg by mouth once daily for 1 week, then 80mg by mouth once daily for 2 weeks

**Name:** Carvedilol CR

**Other Names:**

- Coreg CR

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Atenolol

**Description:** Dose titration of 25mg by mouth once daily for 1 week, then 50mg by mouth once daily for 1 week, then 100mg by mouth once daily for 2 weeks

**Name:** Atenolol

**Other Names:**

- Tenormin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Central Aortic Blood Pressure

**Time Frame:** Measured at baseline and 4 weeks.

#### Secondary Outcomes

**Measure:** Peripheral Blood Pressure

**Time Frame:** Measured at baseline, 2 weeks, and 4 weeks.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* At least 18 years of age
* Hypertension (untreated or treated with no more then one anti-hypertensive drug)

Exclusion Criteria:

* Secondary forms of hypertension (including sleep apnea)
* Patients currently treated with two or more antihypertensive drugs
* Patients taking antihypertensive drugs with properly measured clinic systolic blood pressure greater then 170mmHg
* Isolated systolic hypertension
* Other diseases requiring treatment with blood pressure lowering medications
* Heart rate less then 55 beats/min (in the absence of beta-blocker therapy)
* Known cardiovascular disease including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease (including stroke and TIA)
* Known diabetes mellitus (Type 1 or 2)
* Renal insufficiency defined as a serum creatinine greater then 1.5mg/dL in males and 1.4mg/dL in females
* Primary renal disease
* Pregnancy or lactation
* History of Raynaud's syndrome
* Alcoholism and recreational drug use (due to compliance concerns)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Gainesville

**Country:** United States

**Facility:** University of Florida

**State:** Florida

**Zip:** 32610

#### Overall Officials

**Official 1:**

**Affiliation:** University of Florida

**Name:** Benjamin Epstein, Pharm.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006973

- Term: Hypertension

### Intervention Browse Module - Ancestors

- ID: D000000319

- Term: Adrenergic beta-Antagonists

- ID: D000018674

- Term: Adrenergic Antagonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000959

- Term: Antihypertensive Agents

- ID: D000000975

- Term: Antioxidants

- ID: D000020011

- Term: Protective Agents

- ID: D000002121

- Term: Calcium Channel Blockers

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000077264

- Term: Calcium-Regulating Hormones and Agents

- ID: D000014665

- Term: Vasodilator Agents

- ID: D000058668

- Term: Adrenergic alpha-1 Receptor Antagonists

- ID: D000000317

- Term: Adrenergic alpha-Antagonists

- ID: D000000889

- Term: Anti-Arrhythmia Agents

- ID: D000013565

- Term: Sympatholytics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000058671

- Term: Adrenergic beta-1 Receptor Antagonists

### Intervention Browse Module - Browse Branches

- Abbrev: AnAg

- Name: Antihypertensive Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

### Intervention Browse Module - Browse Leaves

- ID: M1718

- Name: Carvedilol

- Relevance: HIGH

- As Found: B-cell lymphoma

- ID: M4568

- Name: Atenolol

- Relevance: HIGH

- As Found: Minocycline

- ID: M3671

- Name: Adrenergic beta-Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20755

- Name: Adrenergic Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4277

- Name: Antihypertensive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M5384

- Name: Calcium Channel Blockers

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M17412

- Name: Vasodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M29194

- Name: Adrenergic alpha-1 Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M3669

- Name: Adrenergic alpha-Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M4213

- Name: Anti-Arrhythmia Agents

- Relevance: LOW

- As Found: Unknown

- ID: M16344

- Name: Sympatholytics

- Relevance: LOW

- As Found: Unknown

- ID: M29197

- Name: Adrenergic beta-1 Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000001262

- Term: Atenolol

- ID: D000077261

- Term: Carvedilol

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Carvedilol CR

**Description:** Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.

**ID:** EG000

**Other Num at Risk:** 22

**Serious Number At Risk:** 22

**Title:** Carvedilol CR

**Group ID:** EG001

**Title:** Atenolol

**Description:** Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.

**ID:** EG001

**Other Num at Risk:** 19

**Serious Number At Risk:** 19

**Title:** Atenolol

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 22

**Group ID:** BG001

**Value:** 19

**Group ID:** BG002

**Value:** 41

**Units:** Participants

### Group

**ID:** BG000

**Title:** Carvedilol CR

**Description:** Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.

### Group

**ID:** BG001

**Title:** Atenolol

**Description:** Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 19

#### Measurement

**Group ID:** BG002

**Value:** 41

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 13.1

**Value:** 47.7

#### Measurement

**Group ID:** BG001

**Spread:** 9.9

**Value:** 46.1

#### Measurement

**Group ID:** BG002

**Spread:** 11.5

**Value:** 46.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 26

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 15

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 19

#### Measurement

**Group ID:** BG002

**Value:** 41

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** Small sample size, short duration.
### Point of Contact
**Email:** epstein@cop.ufl.edu
**Organization:** University of Florida
**Phone:** 3523590945
**Title:** Dr. Benjamin J Epstein
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10.4
- **Upper Limit:** 
- **Value:** -16.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 18.7
- **Upper Limit:** 
- **Value:** -16.0
**Title:** 
#### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Measured at baseline and 4 weeks.
**Title:** Central Aortic Blood Pressure
**Type:** PRIMARY
**Unit of Measure:** mmHg
##### Group
**Description:** Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
**ID:** OG000
**Title:** Carvedilol CR
##### Group
**Description:** Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
**ID:** OG001
**Title:** Atenolol
#### Outcome Measure 2
**Reporting Status:** NOT_POSTED
**Time Frame:** Measured at baseline, 2 weeks, and 4 weeks.
**Title:** Peripheral Blood Pressure
**Type:** SECONDARY
### Participant Flow Module
#### Group
**Description:** Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
**ID:** FG000
**Title:** Carvedilol CR
#### Group
**Description:** Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
**ID:** FG001
**Title:** Atenolol
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 22
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 19
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 22
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 19
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True