Clinical Trials Logo
  1. Home
  2. Hypertension
  3. NCT00344110
  4. Details
NCT00344110 Clinical Trial

Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension

Hypertension Clinical Trial

Official title:
A Randomized, Double-blind, Placebo and Active-controlled, Multicenter, Parallel-group Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg to Evaluate Efficacy, Safety and Pharmacokinetics in Patients With Mild to Moderate Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00344110
Other study ID # CSPP100A1301
Secondary ID
Status Completed
Phase Phase 3
First received June 22, 2006
Last updated November 16, 2016
Start date June 2006
Est. completion date April 2007

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension

Recruitment information / eligibility
Status Completed
Enrollment 768
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers
Gender Both
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- Age: 20 - 75 years old

- Gender: Male or female

- Status: Outpatients

- Mild to moderate essential hypertension

Exclusion Criteria:

- Pregnant women, lactating mothers, women suspected of being pregnant, or women who wish to be pregnant

- Patients with msSBP >==180 mmHg and/or msDBP >=110 mmHg at Visit 1, 2 or 3

- Patients with or suspected of having secondary hypertension (due to aortic coarctation, primary aldosteronism, etc.)

- Patients suspected of having malignant hypertension

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Aliskiren

Locations
Country Name City State
Japan Novartis Pharmaceuticals Japan

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan
Secondary Mean sitting systolic pressure (msSBP) lowering from baseline to the study end to placebo and losartan
Secondary Successful response; msDBP <90mmHg and/or a reduction of msDBP = 10mmHg
Secondary Control rate; msDBP <90mmHg and msSBP<140mmHg
Secondary The pharmacokinetics / pharmacodynamics
Secondary Safety and tolerability
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A

External Links