Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Patients With Slight Hypertension and Target Organ Damage
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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 |
- 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 ]
- 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:
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
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:
|
Hypertension Erectile Dysfunction Ventricular Remodeling Vascular Diseases Cardiovascular Diseases Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders Pathological Conditions, Anatomical Hydrochlorothiazide Valsartan |
Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013