Recent Updates
Recently added Catalysts

Hydrochlorothiazide

Phase 3

Hypertension | Small molecule | Cardiovascular |Novartis AG|Last Updated: Jun 6, 2011

Target and mechanism

ModalitySmall molecule

Also known as Hydrochlorothiazide (HCTZ), Hydrochlorothiazide (HCTZ))

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Hydrochlorothiazide · 1 trial · 1 indication

Phase 3 1
NCT00396656Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive PatientsHypertension
COMPLETED30 Analytics
PHASE3COMPLETED
Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Injected Sites Compared to NaCl Injected Sites
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 Endpoints

Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Plus L-NMMA Injected Sites Compared to NaCl Injected Sites
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
At end of each treatment period (Week 21 and Week 43)
Mean Post-treatment Microcirculation at NaCl Injected Sites
At end of each treatment period (Week 21 and Week 43)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Valsartan followed by atenolol + hydrochlorothiazide (HCTZ)EXPERIMENTALAfter 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.
Atenolol + hydrochlorothiazide (HCTZ) followed by valsartanEXPERIMENTALAfter 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.

Interventions

NameTypeDescription
AtenololDRUG100 mg tablets orally once a day (od) in the morning.
Hydrochlorothiazide (HCTZ))DRUG12.5 or 25 mg tablets orally once a day (od) in the morning.
ValsartanDRUG80 mg, 160 mg, or 320 mg tablets orally once a day in the morning
Unlock Study Design Details

Eligibility Criteria

Age Range40 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

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...

Countries:GermanySwitzerland
Unlock Eligibility Criteria