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

This study is currently recruiting participants.
Verified by Federico II University, May 2008

Sponsored by: Federico II University
Information provided by: Federico II University
ClinicalTrials.gov Identifier: NCT00687206
  Purpose

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 we 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, we 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 adeguate 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


Condition Intervention Phase
Hypertension
Ventricular Remodeling
Erectile Dysfunctions
Drug: Valsartan 160mg plus HCT 25mg
Phase IV

MedlinePlus related topics:   Erectile Dysfunction    High Blood Pressure   

ChemIDplus related topics:   Valsartan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Efficacy and Safety of Valsartan 160 mg Plus Hydroclorothiazide 25 mg Once a Day in Patients With Slight Hypertension and Target Organ Damage

Further study details as provided by Federico II University:

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 ecocardiography. [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effects of Valsartan 160mg / HCT 25mg on metabolism and erectile function [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   20
Study Start Date:   March 2008
Estimated Primary Completion Date:   May 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: Valsartan 160mg plus HCT 25mg
valsartan 160 mg plus hydroclorothiazide 25 mg a tablet once a day for 6 months

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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 performe ergometry test
  • Anemia (Hb < 12.5g/dL)
  • Cardiac valve disease
  • Arrhythmia
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687206

Contacts
Contact: Serafino Fazio, MD     39-081-746-3737     fazio@unina.it    
Contact: Antonio Ruvolo, MD     39-081-746-3737     ruvantonio@libero.it    

Locations
Italy
Department of internal medicine University Federico II     Recruiting
      Naples, Italy, 80131
      Contact: Serafino Fazio, MD     39-081-746-3737     fazio@unina.it    

Sponsors and Collaborators
Federico II University

Investigators
Principal Investigator:     Serafino Fazio, MD     University of Naples Federico II    
  More Information


Responsible Party:   Federico II University ( Serafino Fazio MD )
Study ID Numbers:   Val25/08
First Received:   May 19, 2008
Last Updated:   May 29, 2008
ClinicalTrials.gov Identifier:   NCT00687206
Health Authority:   Italy: The Italian Medicines Agency

Study placed in the following topic categories:
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders
Vascular Diseases
Genital Diseases, Male
Erectile Dysfunction
Valsartan
Hypertension

Additional relevant MeSH terms:
Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Sexual and Gender Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008




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