Study comparing SPP100 (Aliskiren) 150mg to placebo and to Losartan 50mg with mild to moderate essential hypertension

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220269

Enrollment

743

Registered

2006-07-06

Start date

2006-07-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

investigational material(s) Generic name etc : SPP100 (Aliskiren) INN of investigational material : Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational mat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Primary Outcomes: Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan Secondary Outcomes: - Mean sitting systolic pressure (msSBP) lowering from baseline to the study end to placebo and losartan - Successful response; msDBP =10mmHg - Control rate; msDBP <90mmHg and msSBP<140mmHg - The pharmacokinetics / pharmacodynamics - Safety and tolerability	—

Measure

Time frame

Primary Outcomes: Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan Secondary Outcomes: - Mean sitting systolic pressure (msSBP) lowering from baseline to the study end to placebo and losartan - Successful response; msDBP =10mmHg - Control rate; msDBP <90mmHg and msSBP<140mmHg - The pharmacokinetics / pharmacodynamics - Safety and tolerability

—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026