Phase 3
Completed N=30
Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients
Source: ClinicalTrials.gov NCT00396656 ↗Enrolled (actual)
30
Serious AEs
1.7%
Results posted
Jun 2011
Primary outcomePrimary: Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Injected Sites Compared to NaCl Injected Sites — 61.21; 61.04 Perfusion units
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Injected Sites Compared to NaCl Injected Sites |
61.21; 61.04 | — |
| SECONDARY Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Plus L-NMMA Injected Sites Compared to NaCl Injected Sites |
-9.11; -5.60 | — |
| SECONDARY Difference in Mean Post-treatment Microcirculation at a Sodium Nitroprusside Injected Site Compared to NaCl Injected Sites |
120.65; 128.14 | — |
| SECONDARY Mean Post-treatment Microcirculation at NaCl Injected Sites |
44.78; 50.96 | — |
| SECONDARY Arterial Pressure Waveform Augmentation Index at the End of Treatment |
139.05; 144.51 | — |
| SECONDARY Arterial Pressure Waveform Pulse Wave Velocity at the End of Treatment |
8.07; 7.60 | — |
Eligibility 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 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).
Data sourced from ClinicalTrials.gov (NCT00396656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.