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OpenTrials
Completed

NCT Number: NCT00687206

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Corixil 160/25mg, Cotareg 160/25mg

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.

    Time frame: 3 and 6 months

Secondary outcomes

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

    Time frame: 3 and 6 months

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Efficacy and Safety of Valsartan 160 mg Plus Hydrochlorothiazide 25 mg Once a Day in Patients With Slight Hypertension and Target Organ Damage

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 30, 2008
Registry last updated
Jan 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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