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

This study has been completed.
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT00687206
First received: May 19, 2008
Last updated: January 28, 2009
Last verified: January 2009
  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 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


Condition Intervention Phase
Hypertension
Ventricular Remodeling
Erectile Dysfunctions
Drug: Valsartan 160mg plus HCT 25mg
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 echocardiography. [ 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
Study Completion Date: December 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Valsartan 160mg plus HCT 25mg
valsartan 160 mg once a day for 6 months plus hydrochlorothiazide 25 mg a tablet once a day for 6 months
Other Names:
  • Corixil 160/25mg
  • Cotareg 160/25mg

  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 perform ergometry test
  • Anemia (Hb < 12.5g/dL)
  • Cardiac valve disease
  • Arrhythmia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
Department of internal medicine University Federico II
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Investigators
Principal Investigator: Serafino Fazio, MD Federico II University
  More Information

No publications provided

Responsible Party: Serafino Fazio MD, Federico II University
ClinicalTrials.gov Identifier: NCT00687206     History of Changes
Other Study ID Numbers: Val25/08
Study First Received: May 19, 2008
Last Updated: January 28, 2009
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Erectile Dysfunction
Hypertension
Ventricular Remodeling
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Valsartan
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators

ClinicalTrials.gov processed this record on September 16, 2014