|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00396656 |
|
Date of registration:
|
06/11/2006 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients
|
|
Scientific 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 |
|
Date of first enrolment:
|
December 2005 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00396656 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Germany
|
Switzerland
| | | | | | |
|
Contacts
|
|
Name:
|
Novartis Pharma Ag |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Novartis Pharmaceuticals |
| | |
|
Key inclusion & exclusion 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).
Age minimum:
40 Years
Age maximum:
65 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Hypertension
|
|
Intervention(s)
|
|
Drug: Atenolol
|
|
Drug: Hydrochlorothiazide (HCTZ))
|
|
Drug: Valsartan
|
|
Primary Outcome(s)
|
|
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)]
|
|
Secondary Outcome(s)
|
|
Arterial Pressure Waveform Pulse Wave Velocity at the End of Treatment
[Time Frame: At end of each treatment period (Week 21 and Week 43)]
|
|
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)]
|
|
Mean Post-treatment Microcirculation at NaCl Injected Sites
[Time Frame: At end of each treatment period (Week 21 and Week 43)]
|
|
Arterial Pressure Waveform Augmentation Index at the End of Treatment
[Time Frame: At end of each treatment period (Week 21 and Week 43)]
|
|
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)]
|
|
Secondary ID(s)
|
|
CVAH631BDE06
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|