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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687206
• Other study ID #: Val25/08
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2008
• Last updated: January 28, 2009
• Start date: March 2008
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunctions
• Hypertension
• Ventricular Remodeling

Intervention

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

Locations

Country	Name	City	State
Italy	Department of internal medicine University Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Effects of Valsartan 160mg / HCT 25mg on metabolism and erectile function		3 and 6 months	Yes