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Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Patients With Slight Hypertension and Target Organ Damage

Primary Purpose

Hypertension, Ventricular Remodeling, Erectile Dysfunctions

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Valsartan 160mg plus HCT 25mg
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18-65
  • Gender Males
  • High-normal blood pressure (130-139 mmHg or 85-89 mmHg)
  • First degree hypertension (140-159 mmHg or 90-99 mmHg)
  • Cardiac remodeling (left ventricular concentric hypertrophy

Exclusion Criteria:

  • Coronary artery disease
  • Secondary hypertension
  • Diabetes mellitus
  • Incapacity to perform ergometry test
  • Anemia (Hb < 12.5g/dL)
  • Cardiac valve disease
  • Arrhythmia

Sites / Locations

  • Department of internal medicine University Federico II

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

The aim of this study is to assess if an early and adequate therapy could bring to a better pressure control (even during physical activity) and a regression of organ damage assessed by bicycle stress test and mono-bidimensional echocardiography.

Secondary Outcome Measures

Effects of Valsartan 160mg / HCT 25mg on metabolism and erectile function

Full Information

First Posted
May 19, 2008
Last Updated
January 28, 2009
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT00687206
Brief Title
Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Patients With Slight Hypertension and Target Organ Damage
Official Title
Efficacy and Safety of Valsartan 160 mg Plus Hydrochlorothiazide 25 mg Once a Day in Patients With Slight Hypertension and Target Organ Damage
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with slight increase in blood pressure levels have an increased cardiovascular risk. In particular this has been demonstrated also in subjects with high-normal blood pressure in whom an exaggerated blood pressure increase, during exercise, and structural left ventricular abnormalities have been shown. On the other hand, the last American and European guidelines for management of hypertension recommend more aggressive treatment in young-middle aged subjects to achieve a better control of cardiovascular risk due to blood pressure increase. In agreement with these recommendations the investigators share the idea that a good blood pressure control should be achieved not only at rest, but also during psycho-physical stress conditions that frequently occur during daily life. On this basis, the investigators decided to evaluate the efficacy and tolerability of the association of valsartan and hydrochlorothiazide (160 an 25 mg daily, respectively) in patients with high-normal blood pressure and first degree arterial hypertension with evidence of organ damage. The aim of this study is to assess if an early and adequate therapy could bring to a better pressure control (even during physical activity) and a regression of organ damage without interfering with metabolism and erectile function

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Ventricular Remodeling, Erectile Dysfunctions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Valsartan 160mg plus HCT 25mg
Other Intervention Name(s)
Corixil 160/25mg, Cotareg 160/25mg
Intervention Description
valsartan 160 mg once a day for 6 months plus hydrochlorothiazide 25 mg a tablet once a day for 6 months
Primary Outcome Measure Information:
Title
The aim of this study is to assess if an early and adequate therapy could bring to a better pressure control (even during physical activity) and a regression of organ damage assessed by bicycle stress test and mono-bidimensional echocardiography.
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
Effects of Valsartan 160mg / HCT 25mg on metabolism and erectile function
Time Frame
3 and 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-65 Gender Males High-normal blood pressure (130-139 mmHg or 85-89 mmHg) First degree hypertension (140-159 mmHg or 90-99 mmHg) Cardiac remodeling (left ventricular concentric hypertrophy Exclusion Criteria: Coronary artery disease Secondary hypertension Diabetes mellitus Incapacity to perform ergometry test Anemia (Hb < 12.5g/dL) Cardiac valve disease Arrhythmia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serafino Fazio, MD
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of internal medicine University Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Patients With Slight Hypertension and Target Organ Damage

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