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Trial record 5 of 65 for:    HYDROCHLOROTHIAZIDE AND VALSARTAN

Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients

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ClinicalTrials.gov Identifier: NCT00396656
Recruitment Status : Completed
First Posted : November 7, 2006
Results First Posted : June 6, 2011
Last Update Posted : June 6, 2011
Sponsor:
Information provided by:
Novartis

Brief Summary:
This study evaluated the effect of valsartan on small vessel blood flow in patients with mild-to-moderate hypertension in direct comparison to atenolol and hydrochlorothiazide.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Atenolol Drug: Hydrochlorothiazide (HCTZ)) Drug: Valsartan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multicenter, Cross-over Trial to Evaluate the Efficacy of a 20 Week Treatment of Valsartan 320 mg Versus Atenolol 100 mg in Combination With Hydrochlorothiazide on Microcirculation in Hypertensive Patients
Study Start Date : December 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Valsartan followed by atenolol + hydrochlorothiazide (HCTZ)

After a 2-week washout period, patients were treated with valsartan for 20 weeks followed by one week in which it was tapered off. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.

After a second 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.

Drug: Atenolol
100 mg tablets orally once a day (od) in the morning.

Drug: Hydrochlorothiazide (HCTZ))
12.5 or 25 mg tablets orally once a day (od) in the morning.

Drug: Valsartan
80 mg, 160 mg, or 320 mg tablets orally once a day in the morning

Experimental: Atenolol + hydrochlorothiazide (HCTZ) followed by valsartan

After a 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks followed by one week in which atenolol was tapered off and HCTZ was discontinued. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.

After a second 2-week washout period, patients were treated with valsartan for 20 weeks. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. Patients took valsartan film coated tablets orally once a day (od) in the morning.

Drug: Atenolol
100 mg tablets orally once a day (od) in the morning.

Drug: Hydrochlorothiazide (HCTZ))
12.5 or 25 mg tablets orally once a day (od) in the morning.

Drug: Valsartan
80 mg, 160 mg, or 320 mg tablets orally once a day in the morning




Primary Outcome Measures :
  1. Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Injected Sites Compared to NaCl Injected Sites [ Time Frame: At end of each treatment period (Week 21 and Week 43) ]
    10 µl of acetylcholine (ACH) at 3 concentrations (10-7, 10-8, 10-9 M) was injected intra-dermally at 3 sites on the forearms. NaCl was injected at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. Means for the 3 ACH and the 2 NaCl sites were calculated and compared. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.


Secondary Outcome Measures :
  1. Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Plus L-NMMA Injected Sites Compared to NaCl Injected Sites [ Time Frame: At end of each treatment period (Week 21 and Week 43) ]
    10 µl of acetylcholine (ACH) at 3 concentrations (10-7, 10-8, 10-9 M) plus 10 µl L-NMMA (10-6 M) was injected intra-dermally at 3 sites on the forearms. NaCl was injected at 2 sites. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. Means for the 3 ACH and the 2 NaCl sites were calculated and compared. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.

  2. Difference in Mean Post-treatment Microcirculation at a Sodium Nitroprusside Injected Site Compared to NaCl Injected Sites [ Time Frame: At end of each treatment period (Week 21 and Week 43) ]
    10 µl of sodium nitroprusside at a concentration of 10-7 M was injected intra-dermally at 1 site on the forearms. NaCl was injected at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. A mean for the 2 NaCl sites was calculated and compared to the sodium nitroprusside mean. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.

  3. Mean Post-treatment Microcirculation at NaCl Injected Sites [ Time Frame: At end of each treatment period (Week 21 and Week 43) ]
    10 µl of NaCl was injected intra-dermally at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. A mean for the 2 NaCl sites was calculated. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.

  4. Arterial Pressure Waveform Augmentation Index at the End of Treatment [ Time Frame: At end of each treatment period (Week 21 and Week 43) ]
    Using applanation tonometry, the arterial pulse form measured at the wrist was analyzed using computerized pulse wave analysis. The arterial pressure waveform has two components; the first is the forward traveling wave when the left ventricle contracts and the second is the reflected wave returning from the periphery. The augmentation index is the ratio of the first and second systolic peaks and is used as a surrogate measure of arterial stiffness.

  5. Arterial Pressure Waveform Pulse Wave Velocity at the End of Treatment [ Time Frame: At end of each treatment period (Week 21 and Week 43) ]
    Using applanation tonometry, the arterial pulse form measured at the wrist was analyzed using computerized pulse wave analysis. The arterial pressure waveform has two components; the first is the forward traveling wave when the left ventricle contracts and the second is the reflected wave returning from the periphery. Pulse wave velocity is the speed of the forward traveling wave and can be used as a measure of arterial stiffness since the more rigid the wall of the artery, the faster the wave moves.



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Caucasian; male or female outpatients and age between 40-65 years of age, inclusive.
  • At Visit 2 all patients must have a mean sitting diastolic blood pressure (msSBP) of ≥ 90 mmHg and < 110 mmHg.

Exclusion Criteria:

  • If a single reading for arterial hypertension in msSBP > 180 mmHg or msDBP > 110 mmHg at any visit after randomization.
  • Inability to discontinue all prior antihypertensive medications safely for a period of 2 weeks prior to randomization.
  • Known history of hypotensive symptoms or orthostatic hypotension.
  • Concomitant use of statins or statin intake during the four weeks prior to Visit 1.
  • Known Keith-Wagener grade III or IV hypertensive retinopathy.
  • A history of heart failure (NYHA II-IV).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396656


Locations
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Germany
Investigative Centers, Germany
Switzerland
Novartis Pharma Ag
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
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Principal Investigator: Novartis Pharma Ag Novartis Pharmaceuticals

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Responsible Party: Anna Mitchell, MD, University Hospital Essen, Essen, Germany et al.
ClinicalTrials.gov Identifier: NCT00396656     History of Changes
Other Study ID Numbers: CVAH631BDE06
First Posted: November 7, 2006    Key Record Dates
Results First Posted: June 6, 2011
Last Update Posted: June 6, 2011
Last Verified: May 2011
Keywords provided by Novartis:
hypertension
valsartan
atenolol
hydrochlorothiazide
microcirculation
arterial compliance
pulse wave analysis
Additional relevant MeSH terms:
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Valsartan
Hydrochlorothiazide
Hypertension
Vascular Diseases
Cardiovascular Diseases
Atenolol
Antihypertensive Agents
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
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents