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

NCT00687206 | Completed Phase 4 DMC

• 1 other identifier: Val25/08
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension; Ventricular Remodeling; Erectile Dysfunctions

Outcome Measures

Primary Outcomes (1)

• 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.

  3 and 6 months

Secondary Outcomes (1)

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

  3 and 6 months

Study Arms (1)

1

EXPERIMENTAL

Drug: Valsartan 160mg plus HCT 25mg

Interventions

Valsartan 160mg plus HCT 25mg DRUG

valsartan 160 mg once a day for 6 months plus hydrochlorothiazide 25 mg a tablet once a day for 6 months

Also known as: Corixil 160/25mg, Cotareg 160/25mg

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of internal medicine University Federico II

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Hypertension; Ventricular Remodeling; Erectile Dysfunction

Interventions

Valsartan; Hematocrit

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Hemorheology; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Serafino Fazio, MD

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 30, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 29, 2009

Record last verified: 2009-01

Locations

IT (1)